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Guide for Prefilled Syringe Seminar 2014 Tokyo May 14, 2014
PDA Japan Chapter Medical Device Committee
Chairperson: Daikichiro Murakami
1. 開催日時：2014 年 5 月 20 日（火曜日）～21 日（水曜日）
Date and Time: Tuesday, 20th of May in 2014, and Wednesday, 21st of May
2. ソラシティカンファレンスセンター（JR 御茶ノ水より徒歩 1 分）http://solacity.jp/cc/index.html
ホテル聚楽の西隣り。〒101-0062 東京都千代田区神田駿河台 4-6 電話：03-6206-4855
Sola City Hall の会場は約 400 名収容の部屋で、East と West に二分割され、各々約 200 名（ス
クール形式）収容可能の部屋で、講演会室用と展示室用として二日間開催。
講演会前日の打ち合わせは一階の Room D で行う予定。
Holding place: SOLA city conference centre East and West meeting room (one minute on foot from
JR Ochanomizu Station, Hijiribashiguchit): located in the west of Hotel JURAKU
(Postal Code:101-0062 4-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan Tel: 03-6206-4855)
講 演 会 場 （ West ） 展 示 会 場 （ East ）
Sola City Hall has a space which can accommodate 600 persons and it is designed to be able to divide into
2 depending on the need. Moreover, it is one big attraction that each divided room provides
anteroom.
Sola City Hall is about 400 persons of the accommodation, but the neighbor is divided in two by East and
West and each room can be about 200 persons of the accommodation (school form), so we borrow them as
for a lecture room and an exhibition room respectively for two days. (Room D on the ground floor is
borrowed for the meeting on the day before the lecture.)
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3．趣旨：
厚生労働省による PIC/S（医薬品査察協同スキーム：Pharmaceutical Inspection Convention and
Pharmaceutical Cooperation Scheme）への加盟申請が 2012 年 3 月に行われ、2013 年 8 月に GMP
通知の改訂が行われるなど PMDA（独立行政法人医薬品医療機器総合機構）・県等の行政当局
の加盟実現に向けた動き、また、それに呼応した医療産業の動きも活発に行われている。
近年、医薬品・医療機器を取り巻く世界的環境が大きく変革し始めており、特に医療機器分野
では、高度医療、技術革新による最先端科学に基づく Combination Products の拡大化と複雑化の
影響により、規制対応の考え方が科学的視点とリスクマネジメントの観点から再構築され始め
ている。
FDA は、2013 年 1 月に Combination Products に対する GMP を発出、6 月にはペンや注入装置に
対する技術的考慮事項のガイダンスを発出している。
IMD の報告によると、2016 年迄に、世界的に販売される医薬品のトップ 10 品目の 8 品目、ト
ップ 50 品目のうちの 27 品目が 2～ 8℃の低温貯蔵と取扱いが求められると予想され、EU GDP
のガイドラインが 2013 年 9 月 7 日より実施され、取り組み課題も欧米では着々と進んできてい
る。
欧州 PDA が 2013 年 11 月に開催したプレフィルドシリンジセミナーでは 600 名以上が参加し、
構成材質・使い勝手に関する事、製造方法、リスクを含めた製剤化検討事例などが議題にとし
て取り上げられ、まさに本件に対する技術の進歩と関心の高さを示している。
本セミナーでは、上記の状況を踏まえ、Prefilled Syringe に関する最新の技術と今後の課題と動
向、求められる医薬品の品質、充填包装など、市場、製品品質、製造技術などに関する日米欧
のエキスパートによる講演を予定している。
本セミナーの主要な議論のテーマは以下の通りです。
1). 高度化医療における Prefilled Syringe の役割と重要性
2). Prefilled Syringe に関する PIC/S の視点から求められる品質マネジメントシステム（QMS）
3). Prefilled Syringe 市場に関する国際環境を踏まえた将来展望
4).高齢化に伴うヒューマンファクターエンジニアリングおよび先端科学技術取り込みの必要性
5). Prefilled Syringe の容器に求められる重要特性
6).国内の Prefilled Syringe の普及に求められる課題と欧米の普及状況
Purpose:
Ministry of Health, Labour and Welfare applied to become a member of PIC/S(Pharmaceutical Inspection
Convention and Pharmaceutical Cooperation Scheme) in March in 2012, and PMDA (Pharmaceuticals and
Medical Devices Agency) has been preparing actively for actual participation in it under MHLW.
In late years, the global environment surrounding pharmaceuticals and medical device begins to develop
higher technology from science-based viewpoint, and particularly in the field of medical device, the regulatory
authorities of US, EU, and Japan are pressed to be reestablished in the aspect of quality and risk
management by the influence of expansion of Combination Products and the complexity based on advanced
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science and technology by higher demand for medical-care and the innovation.
In addition, in Europe and USA in late years, the regulations of the GDP (Good Distribution Practice) rapidly
begins to progress, and, a new GDP guideline issued in EMA has been in effect since September 2013.
According to IMD report, eight items of the Top Ten drug products sold worldwide, and top 27 of 50 items
are expected to keep at a low temperature between 2-8 degrees Celsius by 2016.
In this seminar, based on the situation mentioned above, presentations by acknowledged experts relating to
new international market and production technology will be made, and they are involved in solutions of some
problems in Prefilled Syringe and a future trend, the high quality for filling and packaging, including points to
keep in mind in dealing with the quality and risks of a broad range of sterile drugs and medical devices
demanded in the 21st century.
The number of participants 600 or more could be expected at PFS Conference in Basel to be held by
European PDA in November, 2013 and this shows high interest in PFS issue.
The main subjects of the discussion in this seminar are as follows.
1). Important role of Prefilled Syringe in the advanced medical treatment in the 21st century in the world.
2). Quality management system (QMS) which is demanded in PIC/S regulatory aspect of Prefilled Syringe
3).Future trend and prospects about the Prefilled Syringe market: based on findings in global environment
4). Guarantee on aseptic technology to bring in the advanced science and technology for advanced medical
care and aged people with Prefilled Syringe production
5). Important characteristics required for containers of Prefilled Syringe
6). Some key issues required to the spread of domestic Prefilled Syringe and the current situation in Europe
and US
4．セミナープログラム（逐語通訳付き）：Seminar program (with literal or verbatim translation)
【第１日】2014 年 5 月 20 日（火曜日）：9:00～17:30：May 20, 2014, on Tuesday
受付（Reception）: 8:20-9:00
9:00 –9:10 開会挨拶：Opening Speech, Dr. Georg Rössling（PDA Europe 副会長）
1. Introduction
(Session Moderator: Dr. Georg Röessling, PDA Europe)
9:10-10:00 Mr. Joerg Zimmermann, Vetter Pharma Fertigung GmbH
Title: An introduction to syringe processing: the do's and don'ts
シリンジ処理の概要： 注意事項
10:00-10:20 Coffee Break
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2. Keynote Presentations - Regulatory Aspects of Aseptic Manufacturing -
（Session Moderator: 村上大吉郎、株式会社大気社/Daikichiro Murakami,Taikisha）
10:20-11:10 基調講演：Dr. Hirohito Katayama, Bayer Yakuhin Co.片山博仁 バイエル薬品株式会社
Title: Foreign Matter of Injectables and Cosmetic Quality of the Drug Products
注射剤の異物と外観品質について
11:10-12:00 Dr. Tsuguo Sasaki, 佐々木次雄 Former PMDA GMP Expert 元 PMDA エキスパート
武蔵野大学薬学部客員教授、
Title: Environmental- Monitoring Comparison of requirements between ISO, WHO, USP, and JP
環境モニタリング：ISO, WHO, JP, USP の要件比較
12:00-13:00 Lunch & Exhibition
3. Development Aspects & Test Methods
(Session Moderator: 渡邊英二、テルモ株式会社/Mr. Eiji Watanabe, Terumo Co.)
13:00-13:50 Christophe Bureau, Ph.D , Stevanato Group S.p.A.
Title: Value in the field of glass primary containers for biotech formulation
生物製剤処方用硝子製一時容器の製造技術の価値
13:50-14:40 Mr. Andrea Simonetti, Bonfiglioli Engineering S.r.l.
Title: “Non Destructive Method for Pre-Filled Syringes Closure Integrity Testing compared with Dye Ingress
Testing and High Voltage Leak Detection”
“プレフィルドシリンジの閉塞性完全性試験のための非破壊試験法～染料侵入試験や高電圧漏
れ試験との比較において～”
14:40-15:00 Coffee Break & Exhibition
15:00-15:50 Mr. Vinay Sakhrani, Tribofilm Inc. VP
Title: TriboGlide® Silicone-free Lubricant System for Pre-filled Syringes and Cartridges
プレフィルドシリンジとカートリッジ用のトリボグライド®シリコーン不使用潤滑油システム
15:50-16:40 Mr. Masafumi Aramata, Namicos Co. 荒俣章文 株式会社ナミコス
Title: Fluorocarbon Polymer Coated Vial based on Our New Technology
新開発コーティング技術によるフッ素コートガラス容器
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16:40-17:30 Dr. Christian Herget, Becton Dickinson Co.
Title: Translating product performance attributes into improved outcomes: Realising value from meeting the
highest standard
17:40-19:00 Reception Party
【第 2 日】2014 年 5 月 21 日（水曜日）8:30～18:00：May 21,2014, on Wednesday
受付（Reception）：8:10-8:30
4. Manufacturing & Syringe Technology
(Session Moderators: Mr. Gabriele Peron, Stevanato Group, Italy & D. Murakami, Co-chair)
8:30-9:20 Mr. Rajeev Kabbur, Brevetti Angela S.r.l.
Title: Advanced Applications of Blow Fill Seal Technology Including Pre-Filled Syringes
プレフィルドシリンジを含む成形同時充填システム技術の高度利用
9:20-10:00 Ms. Brigitte Reutter-Haerle , Vetter Pharma International GmbH
Title: Track & Trace - New challenges for the packaging of parenteral products
トラック＆トレース 非経口製剤の包装における新たなチャレンジ
10:00-10:20 Coffee Break & Exhibition
10:20-11:10 Mr. NorioYanagisawa, TEVA Pharmaceutical Co. 柳澤徳雄 テバ製薬株式会社
Title: Prefilled Syringe～QM
プレフィルドシリンジ～求められる QM
11:10-12:00 Mr.Carsten Kern, Bausch & Stroebel
Title: Fill and finish in Aseptic Environment for ready to fill Glass Containers
無菌環境下でのプレフィルドガラス容器への充填
12:00-12:50 Lunch Break
12:50-13:40 Mr. Takayuki Tuji, Iwata Label Co.辻 孝幸 株式会社岩田レーベル
Title: Package addressed on high pharmacologically-active drugs
高薬理活性製剤対応パッケージ
13:40-14:30 Mr. Kristian Slavik, OPTIMA Pharma GmbH
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Title: The challenges of stopper insertion from the perspective of a machine manufacturer and possible
solutions
機械製作者および解決可能性の視点からのストッパー挿入の技術的挑戦
5. Devices: Pens, Injectors, needle free Systems
(Session Moderator: 鶴丸 智彦, Mr. Tomohiko Tsurumaru, Manager - Quality Assurance, 3M)
14:30-15:20 Mr. Minoru Oda, 3M Healthcare Limited, 小田実 スリーエムヘルスケア株式会社
Title: Introduction to 3M Microstructured transdermal systems (MTS)
マイクロニードル製剤 最近の開発状況
15:20-15:40 Coffee Break & Exhibition
15:40-16:30 Mr. Steven Kaufman SHL and Mr. Alessandro Morandotti, Nuova Ompi
Title: A Collaborative Approach: Highlighting the importance of increased cooperation between auto injector &
biotech PFS manufacturers.
協調的アプローチ：自動注射器とバイオテクノロジーPFS メーカー間の協力強化
16:30-17:20 Mr. Orfeo Niedermann, Ypsomed AG and Mr. Masahito TAKAHASHI Terumo Co.
Title: Polymer-based Pre-filled Syringes in Combination with a Two-Step Autoinjector
ポリマー製プレフィルドシリンジを使用した２ステップオートインジェクター
17:20-17:50 Panel Discussion
17:50 -18:00 Closing Speech
5. 参加費（Participation fees）
5-1. 40,000 円/人（PDA 会員）、50,000 円（非 PDA 会員）、10,000 円（行政関係者）
※消費税（8％）込み
Seminar fee: JPY 40,000/person (PDA member), JPY 50,000/person (non-PDA member)
5-2 Exhibition fee: Standard sponsorship: JPY 200,000/ one table booth, Silver sponsorship fee: JPY
400,000/ two tables booth, and Golden sponsor ship fee: JPY 600,000/three tables booth.
The following exhibitors are already proposed.
Vetter, Ompi, West/Daikyo, Terumo, Schott, Shibuya Kogyo, SHL, and BD
※If you send to remittance from overseas, to pay bank transfer fee's own expense.
※There is not including a charge of connecting plug for exhibition.
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展示申込要項： 日本語版 英語版
★講演資料は、当日 USB にてお渡し致します。
★参加費のお振込期限：５月７日（水）までにご入金された方に、事前資料公開のご案内（メール配
信）を予定しております。
※テキスト（印刷物）の配布はございませんので、必用な方はプリントアウトしてお持ち下さい。
※事前資料公開のご案内は、5 月 13 日（火）を予定しております。
※尚、万が一ご案内が届かない場合は、お手数ではございますが、下記事務局まで、ご連絡をお願
い致します。
★The presentation material will be distributed with USB on the day of the seminar.
★After the payment is confirmed, the URL which you could browse and download the
presentation material will be noticed. (It will not be informed before the confirmation of the
payment)
★参加者の皆様には終了後、「修了証」を発行する予定です。
Certificate of completion of a course will be issued to participants after the seminar.
6.参加申込方法
参加ご希望の場合は、日本 PDA製薬学会ホームページ（下記「１．参加申し込み」より）また
は、「２．FAX 専用申込書」にてセミナー事務局クリックトライ宛に（FAX：03-5684-1022）、４月
２４日（木）までにお申込み下さい。この締切日以降のお申し込みは、当日会場にて参加受付し
ますが、事前申込みで定員に達した場合は当日申込みは行いません。当日申込みの有無は予
め日本 PDA製薬学会のホームページでご確認ください。
１．参加申込み(Japan side)
２．FAX専用申し込み用紙(Japan side)
〔注意事項〕
※行政関係者は、当日受付にてお支払いをお願いいたします。
※個人会員・法人会員の方は、極力「会員番号」をご入力下さい。また、法人会員の代理出席の方は、
法人会員へご登録の方の「会員番号」と「お名前」を極力ご入力下さい。
※法人会員の代理出席の場合は、参加者様のお名前でお申込下さい。
（法人会員代理出席は参加枠定数を超える場合のみ、ご連絡させていただくことがあります。）
※個人会員の代理出席の方が「非会員」の場合は、参加費の差額を頂戴致しますのでご注意下さい。
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※会員資格の不明な方は、日本 PDA 製薬学会事務局（担当：原田 Teｌ：03-3268-3084）までお問合せ
下さい。
※参加者をご変更される場合は、なるべくお早目に下記事務局までご連絡をお願い致します。
【Oversea Application】
The participants from abroad, please down load and fill in the application form and send
it back to the secretariat by e-mail or FAX (E-mail: [email protected]）.
After receiving your application, the confirmation will be sent. Please remit the
registration fee with bank transfer to the following bank account. Should you need the
receipt, please note it on the application form.
Overseas Application form（For E-mail&FAX）
※ If you are a member, please note the membership number. Without the number,
the application will be received as a non-member.
※ The registration fee (pre-registration) should be paid in advance.
※ The deadline for the payment is Wednesday May 7.
※ The bank handling charge should be covered by the applicants.
※ The refund after the payment should not be accepted for any reason.
※ The receipt will be given at the registration desk on-site.
【Transfer account】
BANK NAME MIZUHO BANK,LTD.
BRANCH NAME Hongo branch
BRANCH No. 075
BRANCH ADDRESS 3-34-3 Hongo, Bunkyo-ku, TOKYO
POSTAL CODE 113-0033
SWIFT CODE MHBKJPJT
ACCOUNT No. 2468486
ACCOUNT NAME NIHON PDA SEIYAKUGAKKAI KAICHOU Terada Katsuhide
★The presentation material will be distributed with USB on the day of the seminar.
★After the payment is confirmed, the URL which you could browse and download the
presentation material will be noticed. (It will not be informed before the confirmation
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of the payment)
７．参加費お振込についてのご案内
お申込み後、請求金額・お振込み口座のご案内を、メール（自動返信）または FAXにてお
送り致します。下記口座へお振込下さい。請求書は別途お送りさせて頂きます。
※行政関係者の方は、当日受付にてお支払いをお願いいたします。
【お振込先口座】
みずほ銀行 本郷支店 普通預金 ２４６８４８６
日本ＰＤＡ製薬学会会長 寺田 勝英
（ニホン PDAセイヤクガッカイカイチョウ テラダ カツヒデ）
・参加費（事前申込）は事前振込み制でございます。
・お振込みに際する振込み手数料は参加者のご負担でお願い致します。
・参加費振込み後のご返金は申し受けできませんので予めご了承願います。
・振込期限は、５月７日（水）迄となっております。
・ 領収証は、当日受付の際にお渡し致します。
・ 振込時は振込名義の先頭に受付番号をご記載下さい。記載が不可能な場合は、
振込日をご連絡頂けますようお願い致します。
【振込明細フォーム】
・上記期日までに参加費事前振込を確認できない方は、事前資料公開のご案内ができません
ので、ご注意下さい。
8. セミナー内容への問い合わせは下記へ。
Contact to the following on further information on seminar details
PDA Japan Chapter, Director responsible to Prefilled Syringe Seminar Daikichiro Murakami
Tel.: 090-7730-9833 E-Mail: [email protected] or [email protected]
9. セミナーおよび会場展示の申し込みは下記へ。Application to the seminar as following;
E-mail: [email protected] Tel: 03-5840-8528 FAX: 03-5684-1022
10．会場近接のホテルは、ホテル聚楽へ：Hotel Reservation
http://www.hotel-juraku.co.jp/ocha/
当ホテルは、本セミナーに受講の方は割引となります。日にちと学会名をお伝え下さい。
ご担当：綱島様
Please contact Mr. Tsunashima who is General Manager of Hotel Juraku.
This hotel would be recommendable for you to book any room at a special rate, which is to be confirmed at a
10
discount price for the guests of the PDA Seminar.
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11．Speakers, Speeches Abstracts and Profiles
5 月 20 日 May 20, 2014, on Tuesday
1. Mr.Joerg Zimmermann
Vetter Pharma Fertigung GmbH
Jörg Zimmermann studied pharmacy in Freiburg, Germany and Cardiff, Wales. He joined Vetter in 1994 as
assistant head of production. His first responsibilities were process development and new product
introductions with a focus on lyophilization process development. For the last 10 years, Jörg was responsible
for the Vetter Site in Langenargen as Director of production, a site with 5 filling lines for aseptically prefilled
injection systems. In September 2010 he changed into the role of Director Process Development and
Implementation. His department is responsible for the development of all primary pharmaceutical processes
and their qualification up to commercialization.
Title: An introduction to syringe processing: the do's and don'ts
シリンジ処理の概要：注意事項
Abstract:
1) processing of staked needle syringes
2) processing of double chamber syringes
3) washing and siliconisation technology
4) siliconisation: analytical methods
5) case study: production line RVS2
6) RABS in operation
7) aseptic process performance data
8) video of the process
2. Dr. Hirohito Katayama, Bayer Yakuhin Co. 片山博仁 バイエル薬品株式会社
Title: Foreign Matter of Injectables and Cosmetic Quality of the Drug Products
演題：注射剤の異物と外観品質について
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Abstract:
Japan is famous for extremely higher standard of pharmaceutical product quality required for foreign matter
of injectables and cosmetic quality of the products.
The reason why such Japanese quality issue is developed because Japanese sensory feeling is different
from the other peoples in the aspect of any quality level which is really required.
As the result of the above quality culture, Japanese pharmaceutical manufactures and relevant companies
have been facing various kinds of challenges to overcome the difference in the quality levels from other
countries.
Although the required level of the inspection method for insoluble matter in injectables is modestly described
in JP 16, the real expectation is being aimed to achieve step higher level.
Focusing this quality issue, some consideration points could be provided on what level is demanded in the
Japanese pharmaceutical market especially from the viewpoint of foreign matter free, and whether such high
standard visual inspection is technically attained in the substantial issue and production capability through
understanding some data.
概要:
日本は世界から突出して注射剤の異物と外観品質に対する市場の要求品質が高い。その理由
は、本当に必要な品質レベルとは何か、それはなぜか、という点で日本人の見方が異なるから
である。その結果、日本の企業は様々な問題と対峙を強いられている。日本薬局方（JP）が要
求する注射剤の不溶性異物検査法の条件は自由度が高いが、実態は、海外よりも一段高いレ
ベルを達成しようとしていることが多い。日本市場が求める異物フリーのレベルとはどのような
ものか、又、目視検査が技術的に可能なレベルはどのようなものか、をデータで理解した上で
生産時にできること、又、問題の本質は何か、を考える。
3. Dr. Tsuguo Sasaki, 佐々木次雄 Professor of Musashino University, Former GMP Expert of PMDA
Title: Environmental- Monitoring Comparison of requirements between ISO, WHO, USP, and JP
演題：環境モニタリング：ISO, WHO, JP, USP の要件比較
Abstract:
As the various standards about the environmental monitoring in the clean rooms or isolators applied to the
manufacturing of sterile products are not so well harmonized in the international aspect as to occasion great
confusion to contractors and users of these facilities and equipment.
ISO 14644 series standard is mainly adopted for the suspended particulates to the semiconductor industry,
and GMP criteria to the pharmaceutical industry has primarily been adopted as the microbial standard.
The environment to produce sterile products is classified such grades as A, B, C, D in the currently existing
GMP to be controlled by particle counts and microbial numbers.
This presentation will express the environment monitoring system in detail in comparison with ISO 14644-1
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（Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness by particle
concentration）、WHO: Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities、The
Environment Monitoring Method in aseptic processing areas in JP 16, and USP<1116> Microbiological
Control and Monitoring of Aseptic Processing Environments
概要:
無菌医薬品製造用クリーンルームやアイソレータ等の環境モニタリングに関する規格は、国際
的観点からは調和されておらず、これら施設や装置の施工業者や使用者に少なからず混乱を
引き起こしている。浮遊微粒子規格は主に半導体産業向けの規格 ISO 14644 シリーズを、微生
物規格は医薬品産業向けの基準 GMP を中心に採用されてきた。現行 GMP では、無菌医薬品製
造環境をグレード分類し、微粒子数と微生物数で管理している。これらの規格の現状並びに将
来展望等について、 ISO 14644-1（Cleanrooms and associated controlled environments: Part 1:
Classification of air cleanliness by particle concentration）、WHO: Environmental Monitoring of Clean Rooms
in Vaccine Manufacturing Facilities、日本薬局方「無菌医薬品製造区域の環境モニタリング法」、
USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments 要件を比較しつつ
述べてみたい。
4. Christophe Bureau, Ph.D
Vice-President, Strategic Innovation Stevanato Group S.p.A.
Via Molinella, 17, 35017 Piombino Dese, Padova, Italy
Email: [email protected] www.stevanatogroup.com
Title: Value in the field of glass primary containers for biotech formulation
演題：生物製剤処方用硝子製一時容器の製造技術の価値
Pharmaceutical companies are more and more facing issues due to a global need towards high/very high API
concentrations in injectable formulations of biotech drugs. The solubility of APIs is usually facilitated by
surfactants which tend however to emulsify the silicone oil used in prefilled syringes, eventually forming
droplets named “particles”. Ahead of this, it is actually a variety of surface and interface phenomena that may
also take place, which were - like silicone oil - non existing in the vial in which the formulation was initially
developed.
This presentation will illustrate a totally new way of approaching drug/container interaction that both solves
the above mentioned technical issues and reduces the total cost of ownership in the development and launch
of biotech drugs
5. Mr. Andrea Simonetti
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Senior Manager, Strategic Initiatives, Bonfiglioli Engineering S.r.l.
Via Rondona, 33, 44049 Vigarano Pieve (FE), Italy
Tel. +39 0532 715631
Title: “Non Destructive Method for Pre-Filled Syringes Closure Integrity Testing compared with Dye Ingress
Testing and High Voltage Leak Detection”
“プレフィルドシリンジの閉塞性完全性試験のための非破壊試験法～染料侵入試験や高電圧
漏れ試験との比較において～”
Presentation Abstract
The presentation is composed of two sections:
1). Background. One of key aspects of Pre-Filled Syringes (PFS) quality control is the assurance of closure
integrity after filling and terminal sterilization. Leaking through the PFS is a crucial defect which exposes the
drug to the risk of contamination. First the presentation explores the various Container Closure Integrity
Testing (CCIT) technologies applicable to PFS containers filled in with medicinal products. Innovative
technical solutions are detailed; controls to be used while managing the CCIT process so to consistently
ensure the required level of quality, stability and repeatability are outlined as well.
2). Case Study. A case study, conducted in collaboration between a leading manufacturer of CCIT
equipments (Bonfiglioli Engineering) and one of the world's biggest producer of vaccines (Novartis Vaccines
and Diagnostics), is then given: data and findings of challenge tests performed as stated in ASTM F2338
“Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method (VDM)”
are here provided. The study demonstrates that an automated Vacuum Decay equipment is effective in
detecting PFS leakages ≤ 5.0 μm. The method and its quantitative measurements were examined in
comparative studies with High Voltage Leak Detection (HVLD) and methylene blue Dye Ingress Testing (DIT)
methods, the final results demonstrating that the ASTM F2338 VDM indicated the highest performance
between test sensitivity, reliability and repeatability. Large sets both of positive-control PFS, with appropriate
laser-drilled holes below and above fill level, and of negative-control PFS, were employed to determine the
15
detection time, process sigma levels and test efficiency indicators. Documented evidence of detection
capability and of false results rate is included in this study as well. Finally, PFS with embedded capillary tubes
were implemented and filled with air / real product to establish their correlation with laser-drilled PFS.
3). Conclusion. This study provides important contributions to foster a better understanding in the adoption of
CCIT approaches..
Key objectives of the topic
Open discussion about:
new developments in non-destructive CCIT of PFS
results of the case study investigation and the challenges encountered
real data
effectiveness of the CCIT methodologies
ways to get the best performance
lesson learned
points to consider
Tags: Pre-filled Syringes, Non-destructive, CCIT, ASTM F-2338, Dye Ingress, HVLD.
Biography
Andrea Simonetti received the M.S. degree in electronic engineering from the University of Ferrara, Italy.
Since joining Bonfiglioli Engineering S.p.A. in 2002 as Validation Manager he has successfully led large scale
commissioning, validation and quality projects for worldwide major pharmaceutical regulated companies.
Standards, risk management, EU and FDA regulatory compliance are significant interests and responsibilities.
He has been part of Bonfiglioli Engineering S.p.A. Steering Committee and senior management team since
2009. Andrea is now the Senior Manager for Strategic Initiatives responsible for the assessment and planning
for continuous improvement, strategies development and implementation, innovation, company business
growth, customer relationship management and technical training. Andrea is a frequent speaker at
conferences and seminars including ISPE, PDA, BFS IOA. In 2010 he started providing stable educational
support to US Food and Drug Administration Office of Pharmaceutical Science. His most recent publications
involve developing Process Analytical Technology and Lean Six Sigma strategies for pharmaceutical
equipments; he is currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity”
re-write task force team.
6. Mr. Vinay Sakhrani Tribofilm Inc. VP
Mr. Sakhrani is the Vice-President of Technology at TriboFilm Research Inc. and directs all research activities and client engagements related to the proprietary Atmospheric Gas Plasma technology in medical and pharmaceutical applications. He is the primary inventor of the TriboGlide technology and has been the principal investigator on numerous Small Business Innovative Research (SBIR) grants awarded by the National Institutes of Health that have partly funded this research. He holds a Master of Science degree from North Carolina State University in Materials Science and Engineering with emphasis on Surface Chemistry and Plasma Processing.
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Title: TriboGlide® Silicone-free Lubricant System for Pre-filled Syringes and Cartridges
演題：プレフィルドシリンジとカートリッジ用のトリボグライド®シリコーン不使用潤滑油システム
Abstract:
By the joint development with Tribofilm Inc. and IVEK Inc., located in USA, a lubrication method of the
silicone-free for syringes is a revolutionary and alternative lubrication system that is superior to the
conventional silicone coating system in stable immobilization on the syringe surfaces.
This technology is applied with a fluorine-type of lubricant by the immobilization based on the plasma
treatment in the process before and after coating.
The process can be applicable to the mass production in a full scale and allows a higher quality control and
better examination to be achieved with proper equipment and devices configured.
内容：米国の Tribofilm 社と米国 IVEK 社との共同開発により、医療用及び製薬向けシリコンフリーの潤滑方
式は、従来のシリコンを使用した方式に代わる、より固定化に優れた革命的な潤滑方式である。この技術
はフッ素系合成潤滑剤を利用するもので、塗布の前後工程によるプラズマ処理の固定化技術も利用して
いる。そのプロセスはフルスケールの量産にも対応でき、より高い品質管理を可能にする機器構成及び
検査を提供する。
7. Mr. Masafumi Aramata, Strategic Planning and Business Development Dept. Namicos Co.
株式会社ナミコス事業開発部 荒俣章文
Title: Fluorocarbon Polymer Coated Vial based on Our New Technology
演題：新開発コーティング技術によるフッ素コートガラス容器
Abstract:
内容： ガラスは、多くの医薬品、特に注射製剤の容器素材として採用され、アンプル、バイアル、
シリンジ用バレルなどに成形され使用されている。これは、完全な透明性とガスバリア性、高度耐
熱性という注射剤容器にとって最も重要な要件をガラスが元来有しているからである。
一方、ガラスには、添加されている金属酸化物由来のイオン溶出、また、高 pH溶液や特定の緩衝
溶液に弱いといった問題があるのも事実である。近年伸長しているバイオ医薬品は、タンパク質の
ような複雑な高分子をベースにしたものが多いことにも鑑み、本邦では以下の観点から、内表面を
フッ素樹脂によりコーティングしたガラス容器について報告する。
1. 撥水性・撥油性・撥粉性
2. ガラスの修飾イオン溶出抑制
3. 乾熱滅菌耐性
4. 耐アルカリ性
5．タンパク質の吸着抑制効果
Glass is adopted as container material for many pharmaceuticals, and applied particularly as ampoules, vials,
barrels for the injectable preparations.
This is because glass has the most important inherent property of complete translucency and gas barrier
17
characteristics, whereby it is well molded as required for containers due to high temperature resistance.
On the other hand, it is a fact that glass has such negative or poor quality as ion elution derived from metal
oxide added to glass, and liable to damage due to high pH solution or a specific buffer.
As biopharmaceuticals increasing n late years are composed of such complicated macromolecular polymers
as the protein-based substances, glass containers, on which a fluoride polymer resin is coated, are reported
in the following aspects.
1. Water repellency / oil repellency / powder repellency
2. Modified ion elution suppression of the glass
3. Dry-heat sterilization resistance
4. Alkali resistance
5. Adsorption depression effect of the protein
8. Dr. Christian HERGET
BD Medical – Pharmaceutical Systems
WW Strategic Marketing Leader – Biotech, BD Medical – Pharmaceutical Systems
Biography
CHRISTIAN HERGET has 18 years of customer focused professional experience holding various national, regional and global sales and marketing positions. He has gathered experience in the fields of hemato-oncology and transfusion medicine, nephrology, cardiovascular disorders, immunology, neuroscience and stem cell research and focused both on research as well as treatment technologies. He joined BD in 2012 as worldwide strategic marketing leader for biotech. In this role, Christian, BD’s spear heads activities to serve biopharmaceutical customers with dedicated solutions adding value to their key business objectives in this highly innovative and dynamic field. Christian holds a master´s degree in biochemistry from the University of Bayreuth and a PhD in biochemistry from the Max-Planck-Institute in Cologne.
Title: Translating product performance attributes into improved outcomes: Realising value from meeting the
highest standards
Abstract:
Seven out of the ten best selling drugs and about 60% of all drugs under development are biologics. Their
huge success and future potential puts them into the focus of all leading pharmaceutical companies.
Due to their very sensitive nature biologics are the most demanding class of pharmaceuticals in respect to
PFS technology. Based on decades of experience and technological innovation Becton Dickinson Medical
– Pharmaceutical Systems (BD) has developed a portfolio of PFS platforms and advanced technologies
addressing the specific demands of biopharmaceutical drugs, companies developing them and patients
taking them.
Aiming to maximize drug/container-compatibility, container/secondary device compatibility and patient
18
friendliness it delivers significant value to biopharmaceutical companies in
Minimizing developmental and commercial risks (e.g. delays in time to market or recalls)
Increasing commercial success potential by gaining patients’ preference
Reducing total cost of ownership
Assuring highest operational excellence
5 月 21 日 May 21, on Wednesday
9. Mr. Rajeev Kabbur Brevetti Angela S.r.l.
Via Zin, N°6, Montebello (VI), 36054 – Italy
+39 0444 474200 (w), +39 320 6656835 (m)
[email protected], [email protected]
Employment history:
1997 to present Manager, Marketing & Regulatory services
Brevetti Angela S.r.l. Implementing sales plans
Building sales proposals
Developing of marketing literature
Strategy of website campaing
Identification and appointment of Agents
Developing information package for Agents
Monitoring of competitors activities
Personnel recruiting and training
After sales service policy and implementation
Territory covered: North, South and Central
America, Europe, Russian and CIS countries
China, Japan, Korea, Indian sub-continent
Middle East
1996 to 1997 Manager, Production Planning
Fresenius Kabi Italia Software development for production planning
Day to day production planning
Resource planing based on marketing forecast
Line balancing
1994 to 1996 Manager, Projects and Marketing
Development of marketing literature
Strategy of advertisement
Monitoring of competitors activities
1991 to 1996 Manager, Regulatory Affairs
Development of validation plan for process and machinery
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Getting approval from US FDA
Developing product files for registration of pharmaceutical product in varios countries
1987 to 1991 Plant Engineer
Iveon Laboratories, Ltd, India Designing maintenance strategies, procedures and methods
Diagnosing breakdown problems
Monitoring and controlling maintenance costs
1984 to 1997 Plant Supervisor
Indian Rayon Industries, Ltd. Maintaining of plant equipment and troubleshooting
Prepare efficient plans for purchase of manufacturing material
Recruiting and training of personnel
Education and qualification
Higher education: Bachelor of Mechanical Engineer
1979 - 1984 Birla Institute, India
Other Skill and achievements: Trilingual: English, Hindi, Italian
Training and worshops on patents application
Updates in pharma regulations
Training on validation plans for process and Machinery
Speaker at conferences from PDA, ISPE, BFS, IOA, Management Forum, Hexagon, Vac-China
Title: Advanced Applications of Blow Fill Seal Technology Including Pre-Filled Syringes
演題： プレフィルドシリンジを含む成形同時充填システム技術の高度利用
Abstract:
10. Ms.Brigitte Reutter-Haerle ,
Director of Corporate Marketing, Vetter Pharma International GmbH
Ms. Brigitte Reutter-Haerle is the Director of Corporate Marketing for Vetter, a leading contract development and manufacturing organization that serves the global pharma/biotech industry. She has held her current position since 2004 and is responsible for the company’s international marketing activities and product and service management. In 2009, she led the communications program for Vetter’s U.S. expansion. Ms. Reutter-Härle joined Vetter in 1996, serving in the company’s sales and marketing function, and transferred to
20
corporate marketing three years later. She began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express Worldwide. Ms. Reutter-Haerle earned a B.A. and a degree in business administration from Baden-Wuerttemberg Cooperative State University. She has served as leader of the Prefilled Syringe Interest Group/Europe of the Parenteral Drug Association since 2007.
Title: Track & Trace - New challenges for the packaging of parenteral products
トラック＆トレース 非経口製剤の包装における 新たなチャレンジ
Abstract: Serialization/Track &Trace is becoming a crucial part. Manufacturers have to take up this new
challenge and incorporate it in their existing processes. This presentation focuses on several aspects in order
to meet the market and customer quality requirements.
The audience will gain insights into
1) Regulatory & Market requirements in serialization and track and trace
2) Project phases to implement a new packaging technology like serialization
3) Customer expectations on a contract manufacturer
11. Mr. NorioYanagisawa, TEVA Pharmaceutical Co. 柳澤徳雄 テバ製薬株式会社
生産本部生産技術部
概要
プレフィリドシリンジを製造するためのアイソレーターおよびバレルの射出成型機を
紹介し、プレフィルドシリンジ製剤の一般的な特徴を述べた後、容器に求められる諸
特性およびアイソレーターを利用した製造方法に触れます。そしてバレルとして一般
的に使用されるガラスとプラスチックの特徴からどのような容器が望まれるのかにつ
いて考察し、さらにプレフィリドシリンジゆえの具体的なリスクについて解説しま
す。そして、そのリスクに対して、生産者側として行っている対応策を発表します。
その上でリスクに再度立ち戻り、将来解決していくべき課題について発表します。
〒506-0802 岐阜県高山市松ノ木町 1040-22 連絡先：TEL 090-6764-7144
Title: Prefilled Syringe～QM
プレフィルドシリンジ～求められる QM
内容：
プレフィルドシリンジの基礎的な特徴および、求められる諸特性についての説明を行い、
21
その原材料の準備工程、製造造工程から包装工程までのポイントとなる点について
発表をします。
またバリデーション時における項目、留意点などについてもふれます。
Abstract:
A lucid explanation about an underlying characteristic of PFS is given and many characteristics with the
preparatory process of the raw materials are also described additionally on some points from manufacturing
process to packing. Some key items for the validation and considerations to keep in mind are also introduced.
12. Mr. Carsten Kern Bausch & Stroebel
Verkaufsbereichsleiter / Area Sales Manager
Tel.: +49 (7904) 701 450 Fax.: +49 (7904) 701 440
Bausch + Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG
Parkstraße 1 • 74532 Ilshofen • Germany
www.bausch-stroebel.de
Carsten Kern joined Bausch + Stroebel for a commercial apprenticeship in 1992.
After completing his degree in business administration he took the position of Technical Sales Manager in
1995.
In this capacity he was responsible for parts of Europe as well as the Chinese market with sales and project
management services for various pharmaceutical applications.
In 2002 he became area sales manager for Korea, Japan, South East Asia and Belgium.
Title: Fill and finish in Aseptic Environment for ready to fill Glass Containers
演題： 無菌環境下でのプレフィルドガラス容器への充填
Abstract:
Bausch + Ströbel, one of the world’s leading manufacturers of pharmaceutical equipment, will present their
new concepts for fill and finish in aseptic environment
for ready to fill glass containers.
22
Today’s principal topics will be the processing of different containers in nests under RABS and isolator.
The high speed processing in nests comprises the steps: tub debagging, removal of foil lid and liner, filling
and closing of syringes, vials and cartridges.
Further processing of containers consists of labelling, plunger rod insertion, assembly of safety devices and
back stops.
13. Mr. Takayuki Tuji 辻 孝幸
Iwata Label Co. 株式会社岩田レーベル
Title: Package addressed on high pharmacologically-active drugs
演題：高薬理活性製剤対応パッケージ
Abstract:
内容：・岩田レーベルの会社概要説明
・代表機能商品の紹介
・高生理活性製剤対応ラベル
抗がん剤注射剤の医療現場における汚染問題について、当社が開発
した「バイアルプロテクパック」を紹介します。
『破瓶』『飛散』『液剤漏出』『表面暴露』
それぞれの問題をクリアした活気的な包装形態をご提案いたします。
14.Dr. Kristian Slavik OPTIMA Pharma GmbH
Sales Director South East Asia & Far East
Biography
Kristian Slavik, Sales Director South East Asia & Far East at OPTIMA pharma GmbH, is an expert in the
South-East Asian market for sterile fill-and-finish packaging machinery.
During his 14 years at OPTIMA pharma he has been developing these markets successfully, making OPTIMA
one of the key players. He is a graduate of Business Administration and Engineering.
Title: The challenges of stopper insertion from the perspective of a machine manufacturer and possible
solutions
23
演題：機械製作者および解決可能性の視点からのストッパー挿入の技術的挑戦
Abstract:
The pharmaceutical demands on machine manufacturers are steadily increasing.
機械製造業者に対する製薬側の要求は、着実に増加している。
In the recent past, clean room classifications (RABS/Isolators) and sterilization processes (UV / H202 /
Plasma / e-beam) were in the focus, today dosing systems (Rotary piston pump, time-pressure, peristaltic
pump) with IPC and stoppering are of great importance.
最近迄は、清浄度区分（RABS/Isolators）と滅菌処理工程（UV/H202/プラズマ/電子線）が焦点となっていたが、
今日、プロセス計装制御（Instrumentation and Process Control）投薬装置類（回転ピストン・ポンプ、時間と圧、
蠕動ポンプ）と栓を装備することは、非常に重要である。
Nested syringe machines must thereby provide a wide variety of performance options.
そうしたことにより、注射器を箱などに重ねて入れる機械は、多種多様な機能のオプションを提供しなけ
ればならない。
Established syringe manufacturers are now offering nested cartridges and vials.
現在において、確立された注射器メーカーは、箱入れされたカートリッジとバイアルを提供している。
Machine manufacturers need to act on such trends with sophisticated and flexible solutions.
機械メーカー精巧で柔軟な解決策でそのような傾向に従って行動する必要がある。
The big challenge when developing a syringe processing line is the handling of different objects such as
syringes, vials and cartridges on a single machine.
注射器の処理工程を開発する場合における大きな挑戦課題は単一つの機械上に管、注射器、バイアル、
カートリッジのような異なる対象物を取り扱うことである。
All these objects are supplied pre-sterilized in trays.
これらのすべての対象物は、トレイで事前に滅菌されて供給される。
15. Mr. Minoru Oda, 小田 実
3M Healthcare Limited, スリーエムヘルスケア株式会社
Title: Introduction to 3M Microstructured transdermal systems (MTS)
演題：マイクロニードル製剤 最近の開発状況
Abstract:
"The microneedle technology" is one of new technologies which can solve problems such as "a pain" or "the
complicatedness of treatment and diagnosis” using the needle.
Microneedle has needles which are less than 1mm height and has sharp form which can penetrate into
stratum corneum.
Studies to deliver drugs which have difficulties transdermally shows good progress recently by several
companies. Clinical studies have been already pushed forward and it is very likely that microneedle will
appear in the market as one of transdermal drug delivery systems in the near future.
I would like to provide a topic about recent development status of a coating/hollow type microneedle which
24
are developed by 3M this time.
【概要】
近年の薬剤学・材料工学・加工技術のさらなる進歩にともない、新たな投与技術や治療・診断技術
が開発され臨床の場で使用されつつある。「マイクロニードル技術」はそれら多くの新しい技術の
一つであり、従来注射針を使用する治療や診断の際の「痛み」や「手技の煩雑性」などの課題を解
決しうる方法として注目されている。
マイクロニードルは、ニードル長さ（高さ）が 1mm 未満で、皮膚の角層を貫通するのに十分な、
鋭利な形状をした先端部分を有する微小な成型物で、多くの場合それら複数が配列している（マイ
クロニードルアレイ）。このマイクロニードルと薬物（難経皮吸収性薬物、ワクチン・タンパクな
どを含む）を組み合わせたマイクロニードル製剤を用いて皮内領域に薬物を送達する研究が進んで
いる。すでに臨床試験も進められており、近い将来医療の現場でマイクロニードル製剤が注射製剤
や経皮吸収製剤と並ぶ、皮膚を介した薬物投与形態のひとつとして市場に登場する可能性も高い。
今回 3M 社のコーティング型及び中空型のマイクロニードル製剤、最近の開発状況について話題提
供したい。
16. Mr. Steven Kaufman (SHL) and Alessandro Morandotti, (Nuova Ompi)
Mr. Steven Kaufman
Marketing Director, SHL Group
Mailing address: SHL Group, 136, Kuo Sheng 2nd Street, Taoyuan, Taiwan 330
E-mail:[email protected]
Phone: +886-3-217-0303 Fax:+886-3-217-4928
Mr. Steven Kaufman is Marketing Director of the SHL Group. He is responsible for global marketing strategy
and reports directly to CEO Roger Samuelsson. Mr. Kaufman also leads business development efforts for
SHL Medical in the Asia-Pacific region. He is actively involved with SHL Medical’s biopharmaceutical
customers and has detailed knowledge of past, current and future auto injector projects. An active member of
key industry associations such as the PDA, Mr. Kaufman has a biopharmaceutical background, broad
25
experience in the drug delivery device field and is involved with strategic alliances with related suppliers. He
has extensive presentation experience and is author/co-author of papers/articles related to this industry.
Title: A Collaborative Approach: Highlighting the importance of increased cooperation between auto injector &
biotech PFS manufacturers.
演題：協調的アプローチ：自動注射器とバイオテクノロジーPFS メーカー間の協力強化
Abstract
Recent launches of injectable biologics have had a direct impact on the demand for PFS as well as devices for self-injection as auto injectors and pen injectors. As a result, device and primary container manufacturers are increasing their levels of cooperation to enhance the compatibility, safety and effectiveness of combination projects that are produced in cooperation with biopharmaceutical companies and related key suppliers. With more injectable biologics in the pipeline, and increasing talk of biosimilars & biobetters coming to market, biopharmaceutical companies are looking more closely at selecting PFS and auto injectors that are not only compatible, but that also help to differentiate their product in the market from other competitors. Both speakers will highlight their respective industry experience and discuss the need for increased collaboration by establishing a more systemic approach. In particular they will highlight the needs from a device manufacturer's point of view and also from a PFS manufacturer's point of view. They will touch on industry trends, examples of cooperation between their companies, testing they have conducted, the impact of regulatory standards, total cost of ownership considerations, the availability of biotech PFS, and more. After the joint presentation, both companies will have expert staff on site in the exhibition area and for private meetings to ensure that any questions from the audience can be answered.
Mr.Alessandro Morandotti
Front End Technical Manager, Nuova OMPI - Stevanato Group
Mailing address: Via Molinella 17, I-35017 Piombino Dese (Padova), Italy
Email: [email protected]
Phone: +39-049-931-8061 Fax: +39-049-936-6151
Background in Electronic Engineering with a master in Biomedical applications and Devices at University of
Padua. Alessandro Morandotti has been working in Nuova OMPI since 2001 covering different positions:
Production Manager, Process Development Manager, Special Projects Leader and leader in the development
of new sterile products within the R&D organization.
26
Now is Globally Managing the Technical and Quality Services of Stevanato Group.
Title: A Collaborative Approach: Highlighting the importance of increased cooperation between auto injector &
biotech PFS manufacturers.
演題：協調的アプローチ：自動注射器とバイオテクノロジーPFS メーカー間の協力強化の重要性
Abstract
Recent launches of injectable biologics have had a direct impact on the demand for PFS as well as devices for self-injection as auto injectors and pen injectors. As a result, device and primary container manufacturers are increasing their levels of cooperation to enhance the compatibility, safety and effectiveness of combination projects that are produced in cooperation with biopharmaceutical companies and related key suppliers. With more injectable biologics in the pipeline, and increasing talk of biosimilars & biobetters coming to market, biopharmaceutical companies are looking more closely at selecting PFS and auto injectors that are not only compatible, but that also help to differentiate their product in the market from other competitors. Both speakers will highlight their respective industry experience and discuss the need for increased collaboration by establishing a more systemic approach. In particular they will highlight the needs from a device manufacturer's point of view and also from a PFS manufacturer's point of view. They will touch on industry trends, examples of cooperation between their companies, testing they have conducted, the impact of regulatory standards, total cost of ownership considerations, the availability of biotech PFS, and more. After the joint presentation, both companies will have expert staff on site in the exhibition area and for private meetings to ensure that any questions from the audience can be answered.
17. Mr. Orfeo Niedermann, Ypsomed AG and Mr. Masahito TAKAHASHI, Terumo Co.
Mr. Orfeo Niedermann
Business Development Director, Delivery Systems, Ypsomed AG
Brunnmattstrasse 6, CH-3401 Burgdorf, Switzerland
Phone: +41 34 424 39 47 Mobile: +41 79 429 46 52 E-mail: [email protected]
http://www.ypsomed.com
Orfeo Niedermann has been with Ypsomed since 2005 working with pharma and biotech partners to develop
and bring to market innovative self-injection systems.
He studied mechanical engineering (MSc ETH ME) and management (MBA BFH) and has worked in
engineering, project management and sales of technical products, and since 2005 in the field of medical
27
devices.
Mr. Masahito TAKAHASHI (Terumo)
Hospital company, Drug & Device Group of Terumo Co.
Tokyo Tatemono Yaesu Building 7F, 1-4-16 Yaesu, Chuo ward, Tokyo, 103-0028 Japan
Phone: +81-3-6742-8461 Fax +81-3-6742-8012 Email: [email protected]
Mr. M. Takahashi is Global Business Development Manager of Global Drug & Device Group – Hospital
company of TERUMO, a global research & development company. Mr. Takahashi joined Terumo in 2001
and has held several positions in R&D/Business Development activities.
He has deeply got involved in development of primary containers for pharmaceutical industry since 2009.
He studied organic synthetic chemistry/applied chemistry and holds a MS degree in Engineering from Keio
University.
Title: Polymer-based Pre-filled Syringes in Combination with a Two-Step Autoinjector
Abstract: ポリマー製プレフィルドシリンジを使用した２ステップオートインジェクター
Auto-injectors are increasingly used for self-injection therapies for improving user’s
convenience and enhancing patient’s compliance, in particular in use with bio therapeutics.
Functional interface of the pre-filled syringe and the application system is essential. The
presentation will address specific performance features achieved with a polymer PFS system
for application with an auto-injector. Applying a novel silicone oil free system with this COP
pre-filled syringe results in specific break-loose and glide characteristics
The joint presentation provides information on assessing this pre-filled syringe by the
application system provider, taking into consideration the recent issued ISO standards for
needle-based injection systems, having automated functions (ISO 11608-1:2012 and ISO
11608-5:2012)
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Exhibitors to PDA PFS Seminar Tokyo 2014
Gold Sponsor
Mailing address: SHL Group, 136, Kuo Sheng 2nd Street, Taoyuan, Taiwan 330 E-mail:[email protected] Phone: +886-3-217-0303 Fax:+886-3-217-4928
About SHL SHL is the world’s largest privately-owned designer, developer and manufacturer of advanced drug delivery devices. We have over 2,600 staff globally, with our primary design centers located in Sweden and the USA and manufacturing centers located in Asia. Final assembly, labeling and packaging services for drug delivery devices are also offered in SHL’s newest facility in Florida. SHL supplies auto injectors, pen injectors and inhaler systems to global pharmaceutical and biotech companies. Significant investment in R&D has enhanced our broad pipeline of “next generation” drug delivery systems. These innovative devices include a range of disposable and reusable injectors with fixed or variable dosing, enhanced precision and the ability to accommodate high viscosities. For additional information visit www.shl-group.com or contact us at [email protected]
SHLグルプは主に三つの事業体から構成されています。
一つはSHLメディカルと言う、大手製薬会社やバイオ医療製造業者に薬物送達デバイスを設計・開発・製造などにサ
ポートしている事業体です。
一つはSHLヘルスケアと言う、介護用品を製造している事業体です。
一つはSHLテクノロジーズと言う、機器などプロジェクトの受託製造事業体です。
もう一つはSHLファーマと言う、この事業体は2012年にアメリカで設立し、主に注射器の最後段階の組み立てと仕上
げをする会社です。
目下、SHLグルプは、スウェーデン・アメリカ・中国・台湾に2600人ぐらいの従業員がいます。
スウェーデンとアメリカに研究・開発と設計センターがありますが、台湾と中国には、最先端の製造工場があります。
29
Gold Sponsor
Vetter Pharma International GmbH Eywiesenstrasse 5, 88212 Ravensburg, Germany
℡：+49-751-3700-0 Fax：+49-751-3700-4000 電子メール：[email protected]
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Collaborating with pharma/biotech clients worldwide, Vetter supports products from preclinical development through global market supply.
Exhibitor Attendees: - Oskar Gold,Vice President Key Account Management & Corporate Marketing - Michael Vetter, Director Business Development Asia - Hermann Piana, Key Account Manager - Joerg Zimmermann, Director Process Development and Implementation (Speaker)
- Brigitte Reutter-Haerle, Director Corporate Marketing （Planning Committee and Speaker）
フェッター社は、シリンジ、カートリッジ、バイアル類の無菌充填を専門とする主要な受託契約開発と製造
を行う組織（CRO と CMO）である。
当社は、モノクローナル抗体、ペプチド、インターフェロン、ワクチン類を含め、生物製剤および他の錯化
合物を用いた広範囲な経験をする。また、当社は世界的に合成医薬品および生物製剤メーカの委託先と
協働して、前臨床開発から世界市場への製品供給に至る広範囲にわたり、製品を下支えしている企業で
もある。
展示の説明参加者は以下の六名：
・オスカー・ゴールド：経理およびマーケティング担当副社長
・マイケル・フェッター：アジア地域の業務開発担当取締役
・ヘルマン・ピアナ博士：経理担当部長
・ヨルグ・チンマーマン：工程開発および生産手法担当取締役（演者）
・ブリギッテ・ロイター・ハーレ：国際マーケティング担当取締役（セミナー計画委員、演者）
・ヘンリク・オベーレ：プロジェクトマネジャー
30
Gold Sponsor
Company profile:
Nuova Ompi – Stevanato Group
Via Molinella 17, I-35017 Piombino Dese (Padova), Italy
Tel: +39 049 9318 061 Fax: +39 049 9366 151
Email: [email protected] Website: www.ompi.it
OMPI is the glass-tubing converter in Italy and among the top- leaders in its market worldwide. The standard production from neutral glass tubing includes, syringes with and without needle, screw neck, pilfer-proof, blow back and pill vials, dental cartridges and pen cartridges and ampoules. OMPI supplies syringes EZ-fill™ clean, sterile and ready to fill. Nowadays this concept is offering the market the advantages of the EZ-fill™ concept for other major container types, including vials and cartridges. This allows clients to continue the trend of delegating services to partner suppliers while improving operational efficiency. The most recent phase in OMPI’s expansion is the construction of a new manufacturing facility for glass containers at a site in Mexico, near Monterrey and the new greenfield state of the art plant in Shanghai.
イタリアのStevanato GroupのNuova Ompi社は、製薬および化粧品用の、硝子管容器を生産している。
中性硝子からの標準生産には、バイアル（ペニシリンとインシュリン用、ネジ頸部、改竄防止、逆流、
ピル）、カートリッジ（ペン型と歯科用カートリッジ）、注射筒（無菌原末）、アンプルなどを含まれる。
ヌオバ・オンピ社は、事前充填可能なシリンジ EZ-fillⓇを清浄な無菌状態で、入れ子状の箱に包装さ
れている。
Nuova Ompi 社はバイアル型 EZ-fill を清浄で無菌状態にして、バイアルやカートリッジを含む主要な医
薬品容器に対応した EZ-fill 概念の長所を満たすことで市場に提供し始めている。
このことにより、顧客が事業効率を改善することで、委託パートナーに対する事業委任を継続する傾
向を可能にしている。
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YPSOMED
Ypsomed is a Swiss based developer and manufacturer of self-injection devices with more than 25 years of
experience and numerous devices on the market. With innovative platform products including pens, pen
needles and autoinjectors Ypsomed can meet virtually all pharma partner needs for self-injection.
Ypsomed Delivery Systems provides a complete range of technologies and services for reliable and
user-friendly self-injection systems for injectables such as insulin, hGH and mAbs. From technical
development and design to manufacturing and packaging, Ypsomed makes a crucial contribution to the
safety and market success of such products. Our customers are pharmaceutical and biotechnology companies
that develop, manufacture and market medications for self injection.
Our modular and proven platform technologies guarantee that Ypsomed injection systems are rapidly
available for clinical studies and market introduction. Innovative and patented technologies offer our
customers user-friendly injection systems with which they stand out successfully in the market. All our
products are characterised by reliable and well-thought-out technical concepts, which are also optimised for
the highly automated manufacture of large series.
With the long experience in the field of self-injection systems you can expect high quality support for the
selection of the primary container, customization of your industrial design, demonstrating dose accuracy,
completing the risk analysis file for your drug application and preparing the device relevant sections for
registration of the combination product.
www.ypsomed.com/yds
イプソメッド株式会社の製品
イプソメッド社の四半世紀にわたる経験
25 年以上の経験を有するイプソメッド社は、開発、製造、医薬品と医療機器のアッセムブリー事業な
どに関して特異な契約ービスを提供している。
FDA に登録された施設で、イプソメッド社は、自社の顧客および規制当局によって定期的に査察を受
けており、米国、欧州、中国、日本を含むすべての主要市場で承認された装置を供給している。
イプソメッド株式会社の製品
イプソメッド社は、注射可能薬（例えば、インシュリン、hGH：human Growth Hormone、ヒト成長ホルモ
ン、mAbs：monoclonal anti-bodies、モノクロナール抗体など）の自己投与用ユーザーフレンドリーな
注射システムの主要な独立した開発・製造メーカーである。
一室および二室ペン型を含む特許を有する革新的なカスタム製品で、イプソメッド社のペン及び安全
ペン針と使い捨ての自己注射装置は、自己注射システム向けの発達する市場で、実質的にすべて
の医薬製剤品及び生物製剤の協働事業企業のニーズを満たすことができる。
32
〒350-0801 埼玉県川越市竹野 1 番地
Tel: 049-233-4651 Fax: 049-233-4655 E-Mail: [email protected]
1 Takeno, Kawagoe-shi, Saitama 350-0801 Japan
Tel: +81 49 233 4651 Fax: +81 49 233 4655 E-Mail: [email protected]
武州製薬は 1981 年に操業を開始したサンド薬品（現在のノバルティスファーマ）の日本にお
ける医薬品製造拠点を基盤に、シオノギ製薬の医薬品製造技術を融合して、1998 年に発足し
た医薬品及び治験薬の受託製造専門会社です。2010 年にシオノギ製薬から独立し、新たな道
を歩んでいます。
武州製薬の企業理念は「最も良い薬を製造し、人々の健康に貢献する」ことです。この企業理
念のもと、徹底した顧客志向に立脚し、品質・技術力を常に向上しながら医薬品の安定供給の
使命を果たしていきます。また、日本だけでなく米国や欧州の GMP 認証を背景に世界中の顧
客から信頼され、存在価値の高い企業になるため、前進してまいります。
Bushu Pharmaceuticals Ltd. is a contract manufacturer of pharmaceuticals and clinical samples. We
were founded in 1998 through a merger of the pharmaceutical manufacturing expertise of Shionogi &
Co., Ltd. with the pharmaceutical manufacturing infrastructure of Sandoz Yakuhin K.K. (the present
Novartis Pharma K.K.). Bushu became independent from Shionogi in 2010, and are now forging our
own path.
Bushu Pharmaceuticals’ corporate philosophy is “to Manufacture the Best Medicines that will
Contribute to the Health and Welfare of the People.” Based on this corporate philosophy, and on a firm
client-oriented foundation, we carry out our mission of providing a reliable source of pharmaceuticals
while constantly striving to improve our quality and technical abilities. We have earned the trust of
clients around the world, thanks in part to our GMP certifications for Japan as well as the US and
Europe. We are well on our way to becoming a company people can trust.
33
BREVETTI ANGELA S.r.l. Via dell’Industria 99 36071 Arzignano (VI) ITALY Tel: +39-0444-474200 fax: +39-0444-474222 e-mail: [email protected]
BREVETTI ANGELA was set up in 1977 by Francesco Consolaro, who was already working intensely inthe field of pharmaceutical packaging from the 1960’s on. Since then BREVETTI ANGELA has closelycollaborated with many in the pharmaceutical industry to address their needs
for primary packaging. Thefruits of its intense effort at the cutting-edge of technology are realised in the latest generation of blowfill-seal equipment series called SYFPACR and LIQUIDPAC.
Simultaneously, other packaging equipment,viz. FLUIPAC, CYNOPAC, MECAS, BAGPAC and SACKPAC, have also been developed by BrevettiAngela, whereas SECUREJECTR pre-filled syringes made on SYFPACR machine are our latestdevelopment. Some of our recent innovation have attracted attention around the globe are: 1. Instant pre-filled syringe 2. Use of barrier technology for BFS machines
3. Innovative device to fill liquid and powder combination device. 4. Vaccine filling on BFS machine 5. Packaging highly active and cytotoxic drugs using Blow Fill seal machines. BREVETTI ANGELA SR L 社は、１９７７年に設立、４０年近い市場経験を有する医薬品・バイオ製剤の無菌充
填包装システムにおけるＢＦＳ最先端技術を取り入れた先駆メーカーです。
当社、特殊低温充填用アタッチメントは、ブロー成形された容器温度を低減できる。
このユニットは、ワクチン充填、バイオ生物学製剤や充填中に熱影響を嫌う処方製品の充填には欠かせない必
需品である。
近年、当社の革新技術の幾つかは、世界中で注目を集めています。：
１． SECUREJECT® プレ・フィルドシリンジの一貫製造ライン
２．ＢＦＳシステム用バリア－テクノロジーの使用
３．革新デバイス－液剤と粉末剤を組み合せ充填できるコンビネーション装置
４．ＢＦＳシステムでのワクチン充填
５．ＢＦＳシステムを用いての高活性薬物と細胞毒性製剤の充填包装
連絡先：
BREVETTI ANGELA SR L．，Via dell Industria 99 (PO Box 175), 36071 Arzignano(VI), Italy
E-mail : [email protected]
Telephone : +39-0444-474200 / Fax : +39-0444-474222
WEB : www.brevettiangela.com
国内総代理店：
シービーエム株式会社
〒341-0018 埼玉県三郷市早稲田３－２９－１６
TEL : 048-959-1561 / FAX : 048-959-1571
E-mail : [email protected]
34
テルモ株式会社
設立：1921 年 9 月
資本金：387 億円
連結売上高：4,023 億円 （2013 年 3 月期）
代表取締役会長 中尾 浩治
代表取締役社長 新宅 祐太郎
社員数：4,813 名（テルモグループ 19,261 名: 2013 年 9 月末現在）
本社所在地：〒151-0072 東京都渋谷区幡ヶ谷 2-44-1
03-3374-8111（代）
事業内容：医療機器・医薬品の製造販売
グループ会社：連結子会社 79 社
持分法適用非連結子会社 2 社、持分法適用関連会社 2 社 ＊2013 年 3 月末現在
事業所：<生産拠点> 24 （国内 5、海外 19） ＊2013 年 3 月末現在
株式：東証一部上場
医療を通じて社会に貢献する
テルモは、「医療を通じて社会に貢献する」という企業理念のもとに、世界初のホローファイバー型人
工肺や、日本初の各種使い切り医療機器など、人々の健康に役立つ様々な製品を、世界 160 カ国以
上で提供しています。
Terumo Corporation Date of Establishment: September 17, 1921 Capital Stock: 38.7 billion yen Net Sales: 402.3 billion yen (for FYE Mar. 2013) Representative Directors: KOJI NAKAO, Chairman
YUTARO SHINTAKU, President Number of Employees: 19,261 (Consolidated) Head Office: 44-1, 2-chome, Hatagaya, Shibuya-ku,Tokyo, 151-0072, Japan
Tel. +81-3-3374-8111 Main Business: Manufacture and sales of medical products and equipment, including pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, vascular grafts, peritoneal dialysis, blood glucose monitoring system, medical electronic, and digital thermometers. Corporate Stock: First section of the Tokyo Stock Exchange
(Code: 4543)
The physicians, led by Dr. Shibasaburo Kitasato, that founded Terumo in 1921 to design and make superior thermometers had a larger goal: healthier living abetted by superior medical technology. The will to contribute to society through better health care still drives every Terumo employee. In the 21st century, Terumo is rising to the challenge of making health care more accessible and suitable to a range of needs, wherever in the world we possibly can.
35
日本ベクトン・ディッキンソン株式会社
本社所在地： 東京都港区赤坂 4-15-1 赤坂ガーデンシティ
事業内容： 医療用・細菌検査用の機器、器材、試薬等の輸入・製造販売
代表取締役社長： ジョン・ハリス
企業理念： “あらゆる人々の健康な生活を応援します”
電話： 0120-8555-90（お客様情報センター）
ウェブサイト： http:/www.bd.com/jp/
BD は世界のベストプラクティスを活かして、1971 年から本格的に日本市場での事業を展開してきま
した。以来、40 年を超える歩みのなかで、R＆D から生産・物流・営業・サポートまで、日本市場に根
ざし、日本独自のニーズを汲み上げながら、グローバルな情報力と技術を駆使して、高付加価値な
製品とサービスを提供してきました。
世界の注射用キット製品分野で採用実績№1 のプレフィル用シリンジ「BD Hypak™」を始め、世界で唯
一の経鼻投与インフルエンザワクチンに採用された経鼻投与型プレフィル用デバイスや、世界初の
皮内投与インフルエンザワクチンで採用されている皮内投与型プレフィル用デバイス、自己投与用
ペン型デバイスなど、革新的な製品を世界に提供し続けています。
Nippon Becton Dickinson Co., Ltd
4-15-1, Akasaka Garden City, Akasaka, Minato-ku, Tokyo
Phone: 0120-8555-90
www.bd.com/jp/
BD(Becton, Dickinson and Company) Pharmaceutical Systems is a global company that develops
and manufactures delivery devices for bio drugs and vaccines. In the coming exhibition, a variety
of drug delivery devices will be exhibited which include BD Hypak SCF™, a prefilled syringe for
tray filler systems.
36
【本社 Head Office】
〒130-0011 東京都墨田区石原 2 丁目 4 番 10 号
営業部 TEL 03（6658）8921 FAX 03（6658）8923
技術部 TEL 03（6658）8933 FAX 03（6658）8935
2-4-10 Ishiwara, Sumida-ku, Tokyo 130-0011 Japan
TEL +81-3-6658-8921 FAX +81-3-6658-8923
e-mail: [email protected] URL: http://www.acuraks.com
【大阪営業所 Osaka Branch】
〒573-0073 大阪府枚方市高田 2-28-12 （株式会社クマエンジニアリング内）
TEL 072（808）8891 FAX 072（852）5850
2-28-12 Kouda, Hirakara-City, Osaka 573-0073 Japan
TEL +81-72-808-8891 FAX +81-72-852-5850
事業目的
・ 製薬、バイオ、診断薬、飲料、健康食品、食品、化粧品業界向けの品質保証機器や各種充填機
の輸入
・ 自働機械、充填ラインの設計・製作
・ 包装機械、プラントメーカー業界向けのチャンネライザー及び前後装置の設計・製作
・ 上記機械の販売、据付け、アフターサービス
Our mission
For over thirty years, Acuraks Inc. has been introducing advanced western test and inspection equipment to
the Japanese pharmaceutical and food industries.
During this period, we are not only as an import company but also provide complete after-sales support, so
customers evaluate us as good as Japanese makers.
By getting valuable experience and technical information by the sales and engineering work, we fabricate the
design technology, which optimize the imported equipment to meet the Japanese customers needs. Moreover,
we will continue to pursue 100% customer satisfaction by thorough after-sales support.
37
SHIBUYA KOGYO CO.,LTD.
INTERNATONAL PLANT SALES DIV.
TEL +81-76-262-1615 FAX+81-76-223-1795
Email : [email protected]
シブヤは、ＧＭＰに適合した装置の製造・販売はもちろん、アイソレータ、滅菌システム、液剤調合設備の
ほか、ロボットによる独自のハンドリング技術や、各種検査機器、バリデーション、生産管理システムなど、
豊富な製品・システムで様々なニーズに対応しています。
これからも、多様な医薬品に対して、長年蓄積した技術と、協力会社の優れた製品を活かし、製薬設備シ
ステムのハードとソフト全てを請負い、最適な生産ラインを構築してまいります。
The GMP compliant range of equipment available from SHIBUYA include a variety of pharmaceutical formulation,
isolator, decontamination, inspection and packaging systems. These systems utilize the latest technology such as
robot handling and automated inspection devices. In addition to supplying equipment SHIBUYA are also able to
offer a full system validation service.
SHIBUYA, working in collaboration with their affiliates, strive to stay at the forefront of current global technological
and regulatory advances and requirements. SHIBUYA are committed to providing their customers with customized
state of the art systems which meet the challenges of the diverse and fast changing needs of the Global
Pharmaceutical Industry.
38
ザルトリウス・ステディム・ジャパン株式会社
〒140-0001 東京都品川区北品川 1-8-11 Daiwa 品川 North ビル 4 階
Tel 03-4331-4300
Fax 03-4331-4301
ザルトリウス・ステディムはバイオ医薬品企業の開発・品質保証・生産部門へ革新的な機器やサービスを
提供するリーディングプロバイダーです。溶出物／抽出物試験 (Extractables/Leachables studies) につ
きましては、プレフィルドシリンジや高分子医薬品容器およびプロセス部材を対象として、世界中の製薬企
業様からいままでに 3,500 件を超える試験を受託しております。国内でも現在までに 300 件を超える試験
をご依頼いただいております。
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for thedevelopment, quality
assurance and production processes of the biopharmaceutical industry.With respect to Extractables/Leachables
studies, we have conducted over 3,500 validation studies for Prefilled Syringes, Rubber stoppers, Bottles, Bags,
and Process fluid contact surfaces. In Japan, over 300 Extractables/Leachables studies were conducted.
39
〒104-0042 東京都中央区入船2-1-1 住友入船ビル2F
TEL: 03-5542-6753 FAX:03-5542-6766
2-1-1 IRIHUNE CHUO-KU TOKYO 104-0042, JAPAN
TEL: +81-3-5542-6753 FAX:+81-3-5542-6766
アルテックは、1976年に、印刷・包装機械を輸入販売する産業機械専門商社として創業し、
内外のお客様に、欧米の最先端のテクノロジーを取り入れた産業機械・機器をご紹介してまいりました。その後、市場
環境の変化とお客様のニーズの多様化に合わせて取扱製品分野を広げ、現在では、
医薬品充填ライン、ICカード関連機器、セキュリティ関連機器、ナノテクノロジー関連機器、
プラスチック・ゴム成形機、3Dプリンター、食品加工機械、水処理装置、
廃棄プラスチック再生処理機械等、多岐に亘る機械・機器群を取扱製品のラインナップに
加えております。
今回は下記のメーカーのカタログ展示を致します。
・OPTIMA pharma社シリンジ及びバイアル充填ライン
・DEVEA社除菌システム
・ＨＳＴ社充填ライン周辺機器
Altech was founded in 1976 as a trading company specializing in the import and sale of printing and packaging
machinery, providing our national and international customers with industrial machines and equipment boasting
the latest technologies from Europe and United States.
Having expanded our product fields since then to meet changes in the market environment and the diverse needs
of customers, we have now added a wide range of machines and equipment to our product lineup, including
pharmaceutical product filling line, equipment related to IC cards, security and nanotechnology, plastic/elastic
molders, 3D printers, food processing machines,
water processing devices, and waste plastic recycling/processing machines.
We will exhibit brochures of following makers this time.
・OPTIMA pharma syringe and vial filling line
・DEVEA disinfection system
・HST peripheral equipment for filling line
40
〒540-0037 大阪市中央区内平野町 2-3-14ライオンズビル大手前 8F
TEL.06-6944-9544(代表) FAX.06-6944-9549
LIONSBLDG., OHTEMAYE 8F 3-14, UCHIHIRANOMACHI, 2-CHOME, CHUO-KU OSAKA 540-0037, JAPAN TEL.06-6944-9544 FAX.06-6944-9549
http://www.namicos.co.jp
ナミコスは、グローバルでユニークな医薬・医療用総合容器提供会社です。そしてその企業
理念は、｢製品をお届けするのではなく、お客様に安心をお届けする｣ということであり、この
ような企業姿勢が評価されて、現在、日本の主要な製薬会社様や外資系の製薬会社様などにお
取引いただいております。
製薬各社の新薬開発競争は激化してきており、また製剤技術などの技術革新には目覚しいも
のがあります。ナミコスは、ガラス及び樹脂などの容器原料、製剤とのインタラクション、製
剤を保護するための内面コーティング、投与デバイスなど、医薬品直接包装資材に関する知識
と経験を活かし、製薬各社の様々な課題解決を行うことにより、お客様にとって容器設計のパ
ートナーとしてなくてはならない存在になりたいと考えています。
Namicos is a unique global supplier of pharmaceutical and medical packaging systems. We hope to deliver
customers not only quality products, but also the assurance to gain customers trust. Our such attitude is
highly apprecaited by our customers, many of whom are major pharmaceutical companies in Japan.
Competition among the pharmaceutical companies of developing new drugs is increasingly fierce, and
remarkable progress can be seen in the innovation of pharmaceutical technology. With enough knowledge
and experience on materials of phamaceutical primary packages such as glass and plastics, interaction with
drugs, appropriate inner surface coating technicque to protect drugs, and drug delivery devices, we would like
to privide solutions to a variety of challenges pharmaceutical companies are facing and by doing so, we hope
to become an indispensable partner to our clients.
41
Bonfiglioli Engineering S.r.l. a TASI GROUP Company Via Rondona, 33 44049 Vigarano Pieve (FE) Italy Tel: +39 0532 715 631 Healthy food to eat, clean bottled water, high quality personal hygiene products as well as pharmaceutical drugs that ensure a healthy lifestyle is made possible through modern packaging protection.Let’s take a look inside Bonfiglioli Engineering. A worldwide leader in quality control solutions.State of the art technology that is in service in laboratories as well as production lines of leading manufacturers around the world including leak testing, visual inspection and head space gas analysis machines. BE offer solutions dedicated to the packaging industry in six market sectors: Food & Beverage, Chemicals & Cosmetics, Aerosol, Metal Cans &Tubes, Plastic and Pharmaceutical.Each product to be inspected need dedicated solution engineered by design teams .The Machine are tailor made to the customer requirements on top quality standard platform and proven technologiesOver 15% of employees are dedicated to Research and Development, a major strength of the company, with experienced engineers and technicians focused on finding world class solutions to client's unique applications.An internal strong team implements validation protocols to show that inspecting packages are compliant with regulatory and final user expectations. Being active part of scientific advisory boards, interest group communities and task forces guarantee absolute quality, integrated in ISO 9001 company quality management system.Inclosing, a network of technical service specialist support clients from operational locations all over the word. Service and support teams assist customers from the beginning of the project throughout the entire life cycle of the equipment. Since 1974, Bonfiglioli Engineering has installed over 4.500 machine globally making a dramatic impact worldwide on the efficiency and the safety in the packaging industry. Bonfiglioli Engineering is part of the largest group in the world uniquely focused on leak testing, measurement and inspection TASI GROUP world Class, World Wide
今日生産ライン、ラボ等、世界で活用されているリークテストは、目視検査とチャンバー方式を利
用したものが主流ですが、BONFIGLIOLI ENGINEERING は、食品/飲料分野、化学/化粧品分野、そして
エアゾール缶、金属缶・アルミチューブ、プラスチック容器、薬品関係のパッケージングに対応し
ています。当社の検査機は専門のデザインチームによるテーラーメイドで、最高基準のテクノロジ
ーとプラットフォームで顧客のニーズに応えます。全社の 15％超が研究開発部門に従事し、その多
くが経験豊富なエンジニアであることが当社の強みであり、顧客のニーズに対し世界レベルのソリ
ューションを提供しております。提供する当社の検査機は、国際 j 基準に即したバリデーションプ
ロトコールに耐えうるものと共に顧客のコンプライアンスに答えるものです。この為、絶対的な品
質保証と当該分野におけるアドバイザイザー的な役割を担う為 ISO9001 を取得しました。また、サ
ービス＆サポート・チームはプロジェクトの開始から生産設備のライフサイクル全体においてネッ
トワーク管理でサポートいたします。1974 年の創業以来、BONFIGLIOLI ENGINEERING は全世界で 4500
台以上を設置し、パッケージング分野に安全性と効率性で広くインパクトを与えております。
BONFIGLIOLI ENGINEERING はリークテスト、計測、検査の世界的グループ、TASI GROUP の一員です。
42
Bausch + Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG Parkstraße 1 · Postfach 20 74530 Ilshofen - GERMANY Phone.: +49 7904 701-0 E-mail: [email protected] Fax: +49 7904 701-222 www.bausch-stroebel.com
Company profile:
The Bausch + Ströbel product range specializes in machines for pharmaceutical primary packaging, including equipment for washing, sterilising/depyrogenating, filling, closing and for washing, sterilising/depyrogenating, filling, closing and labelling of containers such as ampoules, cartridges, disposable syringes, vials and bottles of all kinds. Our systems are designed to comply with the latest FDA and GMP requirements and are available for all capacity ranges, starting from process development and clinical batches to fully integrated commercial production.
Bausch + Ströbel 社(ﾊﾞｳｼｭ・ｳﾝﾄ・ｽﾄﾚｰﾍﾞﾙ)は、医薬品製造に特化した製造装置製作を専門として
います。アンプル・カートリッジ・ディスポーサブルシリンジ・バイアル（ボトル）等の、あらゆる容器を対
象とした、洗浄機・乾燥滅菌機（脱パイロジェン）・充填打栓機・巻締機・ラベラー等の機械をご提供致
します。また、我々のシステムは最新のFDA・GMP要件に対応した設計を行い、プロセス開発・治験
薬製造（小ﾛｯﾄ）・商業用生産までのあらゆるレンジの機械を取り揃えています。
日本バウシュ株式会社 1977(昭和52)年4月 BAUSCH＆STRÖBEL社の1977(昭和52)年4月
BAUSCH＆STRÖBEL社の日本総代理店として設立されました。設立以来、４００台以上の機械が輸
入され、数多くの製薬企業に納入されており、現在も多くの機械が稼動しております。
Exhibitor Attendees: Bausch + Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG Mr. Carsten Kern (Sperker) Verkaufsbereichsleiter / Area Sales Manager
Bausch Japan Ltd. Osaka 日本バウシュ株式会社
Mr.Hideo Seike Sales Department
Head office： 1-2-28 Nakamachidai Tsuzukiku Yokohama, JAPAN
神奈川県横浜市都筑区仲町台1‐2‐28
TEL 045-943-9250 FAX 045-943-9285 E-mail: [email protected]
Osaka office：3-6-4F Okamachi Toyonakashi Osaka, JAPAN
大阪府豊中市岡町3‐6‐4F
TEL 06-6845-5004 FAX 06-6845-5017 E-mail: [email protected]
