NEW PRODUCT INTRODUCTION - CPhI Online · • FMEA risk assessments (Failure Mode and Effect Analysis) • FTA risk assessments (Fault Tree Analysis) • DOE (Design of Equipment)

PHARMACEUTICAL DEVELOPMENT

Our NPI department brings valuable expertise, helping our clients from early stage development (up to phase III) to scale up and full commercial manufacturing and packaging.

NEW PRODUCT INTRODUCTION

• Delivery of cGMP & non-cGMP prototypes

• Small scale production / Small API needs

• High quality prototyping: rapid screening of

formulation options

• Anticipation of potential up-scaling issues:

Early characterization of powders

• Specific equipments: STYL’One compaction

simulator and Procept

FULL DEVELOPMENT PROGRAMNew Product Introduction Department

EARLY STAGE PROGRAM

SCALE-UP & QUALITY BY DESIGN PROGRAMS

TECH TRANSFER

• FMEA risk assessments (Failure Mode and Effect Analysis)

• FTA risk assessments (Fault Tree Analysis)

• DOE (Design of Equipment)

• Statistical data treatment with Minitab software

• Use of STYL’One Evolution equipment to allow effective

QbD with small amount of raw materials & APIs

• Derisked scale-up to commercial scale manufacturing

• Equipment qualification and process validation

QUALITY BY DESIGN

Skyepharma has a proven history of successful technology

transfers at all phases, with professional project

management, technical, and operational expertise to

support even the most complex transfer requirements.

Our qualified and highly-skilled team are exposed tointernational quality standards and experienced atmanufacturing for third-party customers. They will supportyou at every stage during technology transfers.

We are committed to bringing value to your project by

giving you strategic and financial advantage and

accelerating time-to-market.

ORAL SOLID DOSAGE FORMS

We are specialists in development and manufacturing of classic and complex oral solid dosage forms :

Single-layer tablets Multi-layer tablets

Tab-in-tab Tab-in-caps

STATE-OF-THE-ART EQUIPMENT

Unique single-layer, multi-layer, tab-in-tab, tab-in-caps,

industrial press park available.

A development methodology which focuses on

effective drug development. It is a systemic and

dynamic approach that assumes that quality is built in

by design and is continuously improved.

With critical parameters identified, it aims to more

effectively explore the characteristics of molecules in

order to better master the manufacturing process.

ANALYTICAL SERVICES

From development to commercial production phases, we

prioritize agility, expertise and quality.

LABORATORY EQUIPMENTS

• Bioburden tests (EP 2.6.12-13 / USP<61>)• Filtration method• Vitek® → Germs identification • Autoclave (250 L capacity)

MICROBIOLOGY

SAMPLING AREA

• Stability chambers• High capacity (19 chambers)• ICH conditions (25/60; 30/65; 40/75; 30/75; etc)• Refrigerated cond.• Freezer

IDENTIFICATION CHARACTERIZATION & ANALYSIS

• Centrifugation for heat-sensitive products• Surface area and pore size analyzer (BET)• Friability, disintegration, viscosimetry, etc• Brookfield viscosimeter• UV-Visible spectrophotometer (Perkin Elmer)• IR/NIR spectrophotometer (Perkin Elmer)• Karl Fisher (Mettler)• Potentiometry• Pycnometry• Particle Size Analysis by Laser Diffraction

(Malvern)• Total Organic Carbon (TOC)• HPLC : PDA multi-wavelength detector, UV

detector, Refractometer• GC : FID é TCD detectors, Headspace, Gas valve • On and offline dissolution (SOTAX)

QUALITY CONTROL

Our dedicated team ensure the compliance of each excipient or API until the finished product is developed.

Entire analyzes are made according to applicable pharmacopoeias or internal monograph.

• Microbiological and chemical testing of raw materials, IPC and finished product

• Handling and analysis of controlled substances• Handling and analysis of light-sensitive products• Regulatory and documentation upgrade

ANALYTICAL DEVELOPMENT

Product development is closely supported by a highly-experienced team during every phase of thedevelopment process.

• Analytical method development and validation• Analytical method transfer• Process optimization• Registration and commercial stability studies• Qualification of second standards handling for

light-sensitive compounds• Cleaning method development and validation

TEAM FOR YOUR PRODUCT1The analytical team supports our clients during every phase of the development process.

MICROFLUIDIZERT M TECHNOLOGY

The liquid solution or suspension passes through micro-channel(s) and is

subjected to extremely high shear and impact forces to achieve uniform

particle size reduction.

The use of exclusive fixed-geometry interaction chamber and unique way

of scaling up through parallelizing multiple micro-channels guarantee the

process scalability.

M I C R O F L U I D I Z E R T M * T E C H N O L O G Y

BENEFICIAL PHYSICO-CHEMICAL ATTRIBUTES

• Micrometer to submicrometer particle size

• Narrow particle size distribution

ENHANCED BIOAVAILABILITY OF BCS II AND IV COMPOUNDS

• Faster onset of action

• Reduced PK and fed/fasting variability

• Improved dose proportionality

• High drug loading

• GMP• Approx. 15 L / min• Cooling and dagazing

equipment included

High shear zones of Skyepharma commercial production unit

High PressureInlet P1

High ShearZones

High ImpactZone

Low Pressure Outlet P2

* Technology owned by

The obtained liquid solution or suspension is then dried to remove the solvents and produce the dried particulate

system to be further compressed.

MicrofluidizerTM Technology is also of great interest for the ma,ufacture of nano and micro emulsions.

Skyepharma expertise in bioavailability enhancement for oral solid dosage forms.

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Skyepharma commercial Microfluidizerproduction unit

PACKAGING SERVICES

BOTTLE LINEAble to fill any kind of bottle with tablets and capsule.

PRIMARY PACKAGING (ISO 8)

• Plastic and glass bottles loading station• Blowing station with clean air• Tablets and capsules Hopper• Visual Counting Station with 4 inspection

cameras.• Weighing cells before and after the filler head• Cottoning station• Caping station (all king of caps)

SECONDARY PACKAGING

• Horizontal Cartoner• Track&Trace and labelling machine (Tamper Evidence)• Automatic horizontal casepacker including aggregation

camera and labeler• Manual paletization and aggregation of the shipper case

on the palet.

Able to fill any kind of tablets, capsules, in all kind of blisters.

BLISTER LINE

BRAND NEW LINES

SECONDARY PACKAGING

• Inductive sealer• Rotary labelling machine including variable data printing

and OCR • Horizontal Cartoner• Track&Trace and labelling machine (Tamper Evidence)• Automatic horizontal casepacker including aggregation

camera and labeler• Manual paletization and aggregation of the shipper case

on the palet.

PRIMARY PACKAGING (ISO 8)

• Forming Station for both PVCs and aluminium• All kind of feeder for tablets and capsules

The numbered cartons are linked to the shipper cases and finally to the pallets.

• Printing of the shipper case label.• Printing of the pallet label.• Control of labels• Association of cartons and shipper cases• Shipper cases/pallet aggregation

Authentication on the carton.

• Provision of serial numbers.• Printing• Verification• The data are commissioned

SERIALIZATION AGGREGATION

ROUND AND SQUARED BOTTLESUp to 75 bottles per minutes

• Capacity• Caps’s width

• Bottle height• Bottle width

18 to 90 mm

7 to 50 mm

15 to 1000 ml

35 to 180 mm

BLISTERUp to 210 blisters and cartons per minutes

• Depth• Blister lenght

• Blister width

70 to 140 mm

30 to 86 mm

Up to 12 mm

PVC-PVDC-ACLAR-TRIPLEX / AluAlu / Alu

• Materials

• Bottle and Blister• Bottle

Height : 15 to 90 mmLengh : 55 to 250 mmWidth : 20 to 120 mm

• Bottle



CARTON SHIPPER CASE

Documents

NEW PRODUCT INTRODUCTION - CPhI Online · • FMEA risk assessments (Failure Mode and Effect Analysis) • FTA risk assessments (Fault Tree Analysis) • DOE (Design of Equipment)