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Sopot – 9th October 2013

SHAPING QUALITY OF PHARMA PACKAGING

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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

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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

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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

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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.)

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Design: components and devices

3D Drawings 2D Executive Drawings

Rapid Prototyping Pilot Tool

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R&D and Manufacturing competences Design: Moulds

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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

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Regulatory support: Validation Master Plan

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Products: standard monodose DPI Platforms

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Products: customized Monodose DPIs

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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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Manufacturing: special technologies

100% Inspection Systems

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Manufacturing: special technologies

Automated 100% inspection of torques, forces and leakages

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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

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Plastiape Group

THANK YOU, DZIĘKUJĘ