Cleanroom Packaging Protect against contamination

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1 Cleanroom Packaging Protect against contamination Dr. Christoph Strubl STRUBL GmbH & Co. KG Kunststoffverpackungen STRUBL GmbH & Co. KG Kunststoffverpackungen, Richtweg 52, D Wendelstein Tel:+49(0) Fax:+49(0) christoph.strubl@strubl.de -

2 Content 1. Cleanroom production markets and applications 2. Cleanroom process as a value chain 3. GMP-requirements as new benchmarks for packaging quality 4. Risik analyses for packaging materials 5. Requirements for cleanroom packaging materials 6. Paradigm shift: packaging is no more a cost article it is a quality feature Dr. Christoph Strubl Seite 2

Risik analyses for packaging materials 5. Requirements for cleanroom packaging materials 6.

3 1. Cleanroomproduction markets and applications Cleanroom production is installed in a lot of different industries f.e. pharmaceutical, chemistry, medical devices, Life Science and Healthcare incl. BioTech, (Micro)Electronics, Food, Automotive, cleanroom disposables and consumables, cleanroom technologies and materials Products made in a cleanroom environment f.e. pharmaceuticals substances, chemicals, medical devices, implants, vials, tubes, pumps, filters, springs, bottels, fasteners, caps, closures, components made from metal / plastics, textiles Specifics within the pharmaceutical / medtec industry Value chain approach Responsibility for total quality control Responsibility through supply chain management Functions of packaging in the cleanroom-value chain Protection (primary- and secondary packagin Transport (handling, shipping and storing) Information (Identification, Qualitylevel, Sterilization indication) Dr. Christoph Strubl Seite 3

4 1. Cleanroomproduction markets and applications Flexibles (plastics) in cleanroom environment Are used all over the cleanroom value chain All parts (raw material, components, modules, products) have to be packed Flexibles are mainly primary packaging in each rank of the value chain Cleanroom products need to be handled, stored and shipped and they have to guarantee the product s cleanroom quaity Gerresheimer HPT Applications for cleanroom-packaging Dr. Christoph Strubl Seite 4

each rank of the value chain Cleanroom products need to be handled, stored and shipped and they have to guarantee the product s

5 2. Cleanroom process as a value chain The cleanroom process is the entity of all internal and external cleanroom-activities including all handling and manufacturing and packaging processes Finished Product f.e. pharma / medical device Raw material supplier f.e. substance Component supplier f.e. module Module supplierf.e. primary packaging Packaging supplier f.e. Films, Bags Packaging supplier f.e. Films, Bags Component supplier f.e. chemical product Packaging supplier f.e. Films, Bags Raw material supplier f.e. resin Packaging supplier f.e. Films, Bags Raw material supplier f.e. resin Dr. Christoph Strubl Seite 5

e. Films, Bags Packaging supplier f.e. Films, Bags Component supplier f.e. chemical product Packaging supplier f.e. Films, Bags Raw material supplier f.e. resin Packaging supplier f.

6 3. GMP-Requirements: new scope for flexibles Functions Product protection (contamination: particular und microbiology) Process protection (contamination: particular und microbiology) Guidelines focussed on process quality EU-guideline => GMP DIN Primary packaging materials for medicinal products DIN Packaging Management of hygiene in the production of packaging for foodstuffs - Requirements DIN cleanrooms DIN cleanrooms Biocontamination control VDI 2083 (insb Cleanroom technology Consumables in the cleanroom) EUPharmacopoe / USP Guidelines focussed on product quality DIN Packaging for terminally sterilized medical devices VDI 2083 (insb Cleanroom technology Consumables in the cleanroom) EUPharmacopoe / USP VDI 19 technical cleanliness Directives for foodcontact materialseu 2004/1935/ bzw. EU 10/2011 Quality standard ISO 9001 regulates minimum requirements Dr. Christoph Strubl Seite 6

Requirements DIN 14644-1 cleanrooms DIN 14698-1 cleanrooms Biocontamination control VDI 20

7 4. Risikoanalyse Verpackungen Typical contamination causes f.e. Micro organics in the cleanroom atmosphere Impurity by process technology Air borne particles and bioburden by staff No adequate disposables / consumables and medias Particle generating by abrasion No adequate cleaning procedures Packaging: Packaging staff machine environment Material Process Monitoring CONTAMINATION Row material risks Migration between packaging material and product Surface contamination => regulatory affairs Process-Risks Particle generating during handling of packed materials and packaing process within cleanroom environment Contamination risiks Caused by Packaging Logistic-Risiks Transfer activities into cleanroom environments packaging of packaging materials Product-Risiks Technical issues f.e. sealing, leaking, sterility, shelf lifer Dr. Christoph Strubl Seite 7

consumables and medias Particle generating by abrasion No adequate cleaning procedures Packaging: Packaging staff machine environment Material Process Monitoring CONTAMINATION Row material risks

8 5. Requirements to cleanroom packaging materials Content of packaging specification Identification: Articlenumber, technical drawing, product description Physical dimensions and tolerances Raw materials, characteristics, conformity Productquality: cleanliness / BioBurden / inspection plan Processquality: details for cleanliness / cleanroom class / hygiene / monitoring Logistics: packaging specification, Labelling, storage conditions, shelf life Documents: CoA, CoC, Samples Design a GMP/cleanroom-suitable productionsystem Technologie Input Organisation Output Personal Design principles all factors of production have to be designed cleanroom-suitable all acitivites have to be processd cleanroom-suitable GMP is a kind of continuous improvement process GMP is a kind of patchwork process GMP is not ready made but individual Dr. Christoph Strubl Seite 8

specification, Labelling, storage conditions, shelf life Documents: CoA, CoC, Samples Design a GMP/cleanroom-suitable productionsystem Technologie Input Organisation Output Personal Design principles

9 6. Paradigme shift: from cost to quality Adequacy principle packaging used in cleanroom have to comply with the same requirements as products produced in cleanrooms 1. Finished product s quality level specifies the quality requirements for flexible plastic packaging materials 2. The cleanroom level of the cleanroom product specifies the requirements for the packaging manufacturer s production process 3. Only plastic packaging materials produced under GMP-Principles reduce contamination risks for cleanroom products 4. A clean, controlled and low-germ cleanroom environment is the basic requirement for cleanroom suitable packagimg materials 5. A complete documentation of product quality requires a GMP- and cleanroom suitability of all parts, components, moduls including packaging materials Dr. Christoph Strubl Seite 9

The cleanroom level of the cleanroom product specifies the requirements for the packaging manufacturer s production process 3.

10 Contact: STRUBL GmbH & Co. KG Kunststoffverpackungen Richtweg 52 D Wendelstein Dr. Christoph Strubl Tel: +49 (0) Fax: +49 (0) christoph.strubl@strubl.de STRUBL GmbH & Co. KG, Richtweg 52, D Wendelstein Tel:+49(0) Fax:+49(0) strubl@strubl.de -

Christoph Strubl Tel: +49 (0) 9129 90 35 0 Fax: +49 (0) 9129 90 35 49 Email: christoph.

Food Safety and Quality Management System

Introduction The company has planned, established, documented and implemented a food safety and quality management system for the site, which is maintained in order to continually improve its effectiveness