2
Introduction
Shaping: bringing a concept it to its material reality
In doing so: building up its quality step by step
This is necessarily done together with the customer
Packaging as vehicle for communication and marketing also in the “conservative” and “traditionalist” pharma environment
Design issues are taking more and more relevance also in the pharma industry
Mainly but not only for OTC
3
Osnago-Italy
- Total area: 50.000 sqm
- Offices: 2.800 sqm on 4 floors
- Factory A: 17.400 sqm (150 sqm clean room)
- Factory B: 2.000 sqm (2.000 sqm clean room)
- Factory C: 4.000 sqm (1.500 sqm clean room)
Sirone-Italy
- Total area: 33.000sqm
- Factory D: 10.000 sqm (600 sqm clean room)
Garwolin-Poland
- Total area: 28.000 sqm
- Factory: 4.000 sqm (150 sqm clean room)
The Group: manufacturing locations
4
The Group: business figures (year 2012)
-Year of foundation: 1970
-No. of employees: 300
-Turnover: 51.600 K€
group turnover by business sector
Medical devices
Personal Care
Packaging Pharma
others
group turnover by geography
Italy
Poland
CEE
EXTRA CEE
5
Research & Development
Quality must start at the design stage
Clear definition of User Requirements is essential to your designing and manufacturing partner in order to carry out a robust design of the product and of the process
During the product development it is essential a constant positive ‘crossed contamination’ between customer and supplier in order to identify:
- patient requirements
- authorities requirements
- customer manufacturing requirements
Which are then transferred into appropriate, efficient and mutually agreed
- control criteria
- control methods
- control instruments (whenever possible)
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R&D and Manufacturing competences
1. Device Design & Engineering
2. Design for Moulding, Design for Assembly, Design for Automated Inspection
3. Rapid Prototyping
4. Pilot and Multicavity Mould Design
5. Automated Assembly Line URS and Co-Design
6. Process Engineering
7. Clean Room Production
8. Equipment Validation
9. Regulatory Support (DMF, Risk Analsyis, CE Conformity etc.)
9
Regulatory support: competences
Controlled Design Development
Risk Analysis, including Design and Process FMEA
Essential Requirements check list
Technical Files to support CE marking
Preparation and filing of FDA Type III Drug Master Files
Process, environment, and computer validation
13
Manufacturing: clean rooms for Injection Moulding
Injection moulding department installed in class ISO 8 (operational) conditions
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Manufacturing: clean room for ISMB bottles and Jars
Injection-stretch-blow-moulding machines installed in ISO8 (operational) Clean Rooms
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Manufacturing: clean rooms for automated assembly and inspection
Assembly lines installed in state of the art ISO7 (operational) Clean Rooms
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Manufacturing: special technologies
The assembly lines are including several combined technologies like inter alia : laser etching, pad-printing , ultrasonic welding, fully automated glue dosing and UV curing, optical and mechanical inspection systems.
(Some examples at next slides)
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Laser Marking
4 colour pad printing in line with clean room assembly
Manufacturing: special technologies
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BOTTLES MANUFACTURING TECHNOLOGIES
• EBM : Extrusion BlowMoulding
- Tooling cost: low
- customization opportunities : high at low cost
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BOTTLES MANUFACTURING TECHNOLOGIES
• EBM : Extrusion BlowMoulding
- multilayer multimaterial : an opportunity also for pharma ?
- but multilayer is expensive for pharma not allowing recovery
of sprue
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BOTTLES MANUFACTURING TECHNOLOGIES
• IBM : Injection BlowMoulding
- Tooling cost: high
- customization opportunities : high at high cost
- injection moulded neck clean profiles and
tight dimensional tolerances in the critical fitting areas
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BOTTLES MANUFACTURING TECHNOLOGIES
• ISBM : Injection Stretch BlowMoulding
- Tooling cost: very high
- Transparency (PET)
- Customization opportunities : high at high cost
- Injection moulded neck clean profiles and
tight dimensional tolerances in the critical fitting areas
- Highly controlled and highly stable process
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BOTTLES MANUFACTURING TECHNOLOGIES
• ISBM : Injection Stretch BlowMoulding
-one customer recently decided to switch from EBM and IBM white
bottles and closures to ISBM transparent uncoloured PET
-switch was in this case also driven by a strong accent onto
communication and marketing issues i.e. emphasizing the
absolute cleanliness & transparency of its own product
(sterile solution for contact lenses)
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The Group: some references…
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•Our mission is to co-develop ideas with customers and give them
shape and reality
•We stop talking here – in compliance with the latin wording
“Labor non clamor”
which surrounded our original logo and inspired our
company name
• “Ape” in Italian means in facts “bee” and “Labor non clamor” in ancient
latin means “work hard, precisely and silently”, like a bee