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Stawiając czoła przyszłości farmacji -
pakowanie,znakowanie,logistyka
Innowacje w projektowaniu bezpośrednich
materiałow opakowaniowych
V Kongres Swiata Przemysłu Framaceutycznego
Marek Miszczak
Dyrektor ds. Rozwoju
__________ Gerresheimer Plastic Packaging
1 10/14/2013
Gerresheimer –opakowania z tworzyw sztucznych
• formy płynne
2 10/14/2013
Gerresheimer –opakowania z tworzyw sztucznych
• formy suche
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Gerresheimer –opakowania z tworzyw sztucznych
• Opakowania PET
4 10/14/2013
Gerresheimer Plastic Packaging
Udział w runku
Asia 4,4%
Germany 10%
Rest of Europe 9,1%
Other 6,9%
France 5%
Poland 4,5%
South America 49,5%
Spain 10,6%
Ophthalmic 15,1%
Solid 25,3%
PET packaging 42,7%
% by region % by product segment
Other 10,6%
Personal care 6,3%
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Opakowania do leków ocznych i donosowych
Opakowania kompletne: butelki, nakrętki zakraplacze, aplikatory
Certyfikaty ISO 9001 / 14001 / 15378
FDA DMF- Type III
Pełna dokumentacja wyrobów gotowych
Zgodność z wymaganiami EuPh i USP
Usługi dodatkowe
Badania mikrobiologiczne i chemiczne
Charakterystyka produktów:
Nakrętki z pierścieniem gwarancyjnym, child resistant, senior-friendly
Grawerowanie
Szeroki zakres pojemności (3 ml – 250 ml)
Zakraplacze dostosowane do wymagań klienta
Znakowanie kolorami
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Dropper bottle systems, nebulizers and spray bottles
Plastic Packaging product ranges: ophthalmic and nasal applications
DROPPER BOTTLE
SYSTEM B >>>
DROPPER BOTTLE
SYSTEM Q >>>
<<< DROPPER BOTTLE
SYSTEM CL
OTHER APPLICATIONS
Nebulizer bottle systems
spray bottle systems
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Denmark, Poland and Spain
Centers of excellence in Europe
Gerresheimer
Haarby
Tablet containers
Gerresheimer
Vaerloese
Tablet containers
Gerresheimer
Boleslawiec
Droptainers
Gerresheimer
Zaragoza
PET bottles Gerresheimer
Valencia
Droptainers
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Własne narzędziownie
Centra rozwojowe
CAD, CAM: Proengineer-3D
Autocad, SolidWorks
Rapid prototyping
Laboratoria pomiarowe
CMM (coordinate measuring machine)
Smartscops
Laboratorium mikrobiologiczne i chemiczne
Bio burden test
Particle counting
Słuchamy naszych klientów...
Polityka jakości
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9
10 zakładów na 3 kontynentach
Lider w Europie i Ameryce
Południowej
Najwyższa jakość
Ponad 400 maszyn, IBM, IM, ISBM,
ML ,EBM, CBM
Systemy wizyjne
Automatyczne procesy pakowania
Know-how w przetwórstwie tworzyw sztucznych
Gerresheimer Plastic Packaging
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Rozwój nowych produktów i zarzadzanie projektami
Gerresheimer Plastic Packaging
Preparation of Input Data
Review of Input Data
Preparation and Approval of Project
Project Plan Distribution
Implementation of Project Activities
Project Verification
Project Validation
Preparation and Distribution of FPS- Project Completion
1. Jasno zdefiniowana
ścieżka projektowania,
zgodnie z PMBOK
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Rozwój nowych produktów i zarzadzanie projektami
Strengths of Gerresheimer Plastic Packaging
2. Statystyczna kontrola
dla wszystkich
procesów
produkcyjnych
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Nowe podejście do projektowania
Strengths of Gerresheimer Plastic Packaging
3. Implementation of Quality by Design
- Design of any information-gathering exercises where variation is
present, whether under the full control of the experimenter or not.
- Important part of QbD, where correlation between critical product and
process parameters must be understood and confirmed.
4. Implementation of Design of Experiments
- Systematic approach to product, process design and
development, where all critical sources of variability
are identified and understood.
- Quality is achieved already at the beginning
of product shelf life .
- Approach does replace the Quality by Inspection.
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Quality by Design in practice/ DoE-design space
Pharma understanding – R&D
Experiment:
3 factors
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4.Design of experiment
Quality by Design in practice/ Critical process parameters-DoE
Pharma understanding – R&D
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Quality by Design in practice/ analyze data
Find corelation between process and products parameters
T 1
T -1
21,00
21,05
21,10
21,15
21,20
-1D
1D
21,15-21,20
21,10-21,15
21,05-21,10
21,00-21,05
C 1
C -1
21,00
21,05
21,10
21,15
21,20
-1D
1D
21,15-21,20
21,10-21,15
21,05-21,10
21,00-21,05
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Zarządzanie ryzykiem i kwalifikacja
Strengths of Gerresheimer Plastic Packaging
4. Risks analysis focused
on product and processes
- People (Communication, training)
- Methods (Incorrect standard work charts)
- Machines (Fixtures)
- Materials (Incorrect parts delivered to line)
- Measurements
5. A strong Qualification
Plan including:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ).
with
SAT = site acceptance test
FAT = Factory acceptance test
UAT = User acceptance test
USR = User system requirement
17 10/14/2013
Gerresheimer Plastic Packaging
Innovative packaging solutions
18 10/14/2013
MultiShell®: High-performance multilayer vials
for parenteral and diagnostic applications
Our Innovation: a MULTILAYER vial with strong combined performances
Inner layer – COP
(Cyclic Olefin Polymer)
secures
lowest level of drug-container interaction
Middle layer – PA
(Polyamide)
is responsible for the
improved barrier and
break resistance
Outer layer – COP
(Cyclic Olefin Polymer)
protects inner layers
and have
glass-like transparency
- Improved compatibility
- Reduced adsorption
- Minimized degradation of
the solution
- better drug stability over
shelf-life
- safety for operators,
caregivers and patients
- smooth surface
- ease the inspection and
improve quality impression
Winner of German
Packaging Award 2011
Finalist of the CphI
Innovation awards2011
19 10/14/2013
MULTISHELL® vials:
Standard, Ready to Sterilize (RTS) and Ready to Use (RTU)
Main characteristics:
Unique oxygen barrier
Superior break resistance
Reduced protein adsorption to container surface
Inert over a wide pH range
Excellent drainability
No heavy metal ion release
Available in 2, 5, 10, 15, 50 and 100 ml
For challenging formulations:
Larger molecules (protein-derived compositions)
Unbuffered solutions, low-volume fill
Aggressive complexing agents (citric acid, EDTA)
Solutions that are sensitive towards metal ions (i.e. Na, Al,
B, Fe, Ti)
Contrast media which contain radio isotopes tending to ion exchange
Drug formulation with high pH-value
High potency and toxic drug solutions i.e. cytotoxics, growth hormones / (Safety for caregivers)
20 10/14/2013
MULTISHELL® vials
Available in 2, 5, 10, 15, 50 and 100 ml
22 10/14/2013
MultiShell® RTU values
How can we support customers fill/finish operations ?
Glass vial unpacking
Vial washing
Vial sterilization
ASEPTIC FILLING
LINE
Stopper setting
Crimping
Inspection
Stoppers
Stopper washing
Stopper sterilization
Crimping caps
Sterile filtration
Bulk solution
Class A, ISO 5
Class C, ISO 7
LF-area
MULTISHELL®
DELIVERED
ON TRAYS
RTU, Ready-to-Use
reduce the intermediate processing
steps at a minimum.
23 10/14/2013
MultiShell®: Reduced degradation by oxidation
HIGH OXYGEN BARRIER
30 to 40 times less than monolayer vials
Significantly reduced gas permeation
0
0,01
0,02
0,03
0,04
0,05
Monolayervial
Multilayervial
cm
³/via
l*24h*1
bar
Oxygen transmission rate *)
*) Test method according to ASTM D3985:95
with complete vial at 23°C, 85% RH and 100%
O2-partial pressure
High barrier
Low barrier
24 10/14/2013
MultiShell®: Improved safety and reduction of production loss
BREAK RESISTANCE and INTEGRITY
Improved resistance
against impact or dropping
Superior impact resistance
of middle layer keeps integrity although outer layer is cracked
Weight of ball (g)
Drop height (cm)
Energy (Joule)
Result
43,5 38,5 0,164 not cracked
63,8 80,0 0,500 not cracked
129,9 80,0 1,020 not cracked
Test method : Vial is filled, stoppered and crimped.
The integrity test has been performed according to
the
Defect Evaluation List for blow-moulded plastic
containers. Vial on the right side has been
intentionally
damaged for the purpose of the integrity test.
In-house developed test method:
Vial is placed in a rectangular cavity
below a tube.
Metal balls with defined mass are
dropped through the tube on the vial.
Drop height is varied and measured to
achieve different impact energies.
Vial
Tube
Ball m
0 cm
20 cm
40 cm
60 cm
80 cm
25 10/14/2013
MultiShell®: Reduced adsorption and
very low level of extractables
Multilayer Plastic Vial shows less
absorption than glass vials
Test procedure:
First rinsing with Acetone followed by a second rinsing with WFI
Treatment with 20% Bovine Serum Albumin (BSA)
solution for 24 h
Treatment with 0,1% Coomassie Violet R200 dye
solution for 24 h
No metal ion release above the detection limits of 7-30 pbb
Element test solution (ppm) blank solution (ppm)
Aluminium < 0,021* < 0,021*
Barium < 0,007* < 0,007*
Boron 0,089** 0,055**
Cadmium < 0,006* < 0,006*
Calcium 0,12** 0,56**
Chromium < 0,007* < 0,007*
Cobalt < 0,014* < 0,014*
Copper < 0,014* < 0,014*
Iron < 0,014* < 0,014*
Lead < 0,021* < 0,021*
Magnesium < 0,021* < 0,021*
Manganese < 0,003* < 0,003*
Molybdenum < 0,011* < 0,011*
Nickel < 0,014* < 0,014*
Potassium 0,18** 0,17**
Silver < 0,007* < 0,007*
Sodium 0,66** 3,32**
Zinc 0,016** 0,016**
* Concentrations are below detection limits of
7-30 ppb.
** Boron, Calcium, Zinc and Sodium
concentrations are from glassware of analytical
equipment, see results from the blank solution.
Test method: Vials are extracted
with WFI under reflux. Resulting
solution is analyzed by Inductive
Coupled Plasma/Optical emission
spectroscopy
26 10/14/2013
Sterilization process and
Post-sterilization performance
ONGOING ACTIONS FOR THE VALIDATION OF MULTISHELL® RTU REGULATORY
COMPLIANCE
MULTISHELL®
RTU
1.Sterilization validation incl. Dose setting+Mapping
2. Packaging validation
2.1) Package transport simulation (simulation of transport by shake-shock & drop test)
2.2) Package integrity validation (testing of package before and after transportation challenge)
2.3) Package microbiological challenge
3. Product post-sterilisation performance
(Performance tests at various time pulls)
ISO 11137
ISTA 3E
ISO 11607
EMA guideline 3AQ4a
√
Sterility testing Supportive documentation / Certified per batch Parametric release √
Multilayer plastic vials can be sterilised by traditional methods:
Steam (121°C, 20 min)
ETO (45°C, 6 h, c = 600mg/l ETO)
E-beam (25 kGr)
Gamma radiation (25 kGy) selected for MULTISHELL® RTU
27 10/14/2013
Thank you for your attention !
Krzysztof Dabrowski
Sales Director, Primary Plastic Packaging
Mobile: +48 75 7350 500
Marek Miszczak
R&D Director
European R&D Coordinator
Mobile: +48 75 605 966 686
