CONTRACT PACKAGING

Product catalog summary

Overview: This document outlines the procedures and standards for contract packaging in a Cleanroom Class 7 environment, as per ISO 14644-1, focusing on medical packaging.

Specifications: The packaging process is conducted in a cleanroom environment to ensure low-germ and low-particle conditions. The facility is certified to ISO 13485:2016, ensuring compliance with medical device quality management systems.

Procedures:

Incoming Goods Inspection: Products are inspected upon delivery for completeness and quality. Any discrepancies are reported to the customer.
Cleaning and Final Rinsing: Pre-cleaning is done using ultrasonic baths, followed by a final rinse with highly purified water (HPW) in compliance with Ph.Eur.6 standards.
Assembly and Packaging: Parts undergo visual inspection and functional checks before assembly. Packaging is done using validated processes, with options for sterile or non-sterile packaging.
Label Printing and Sealing: Labels are printed to ensure traceability, and sealing lids made of Tyvek® can be printed under cleanroom conditions.
Sterilisation: Products are sterilised through external partners using gamma irradiation or ethylene oxide, with other methods available upon request.
Final Packaging: Products are placed in labelled sales packages with inserts and patient labels, then boxed and palletized according to a validated loading plan.
Chilled Product Storage: Chilled storage is available for up to 1,445 litres, ensuring controlled temperature conditions before and after production.

Project Management: Project managers and engineers collaborate with customers to develop cost-effective and tailored solutions for new application techniques.

Contact Information: MEDIPACK AG, located in Schaffhausen, Switzerland, with a subsidiary in Singen, Germany, provides contact details for further inquiries.

Catalog excerpts

CONTRACT PACKAGING in Cleanroom Class 7 (ISO 14644-1) QUICK AND RELIABLE Project management / engineering Incoming goods inspection Label printing Cleaning and final rinsing Assembly Final packaging Sterilisation Chilled product storage

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CONTRACT PACKAGING Our customers trust us to package their high-quality products. Project management / engineering Together with the customer, our project managers and engineers develop an optimal and costeffective solution as well as tailor-made concepts for new application techniques. Contract packaging incoming goods After an inspection at delivery, the products arrive at the incoming goods station of the Contract Packaging department. Here the documents are inspected for completeness and a customer-specific quantity check is carried out. If we find any incorrectly delivered or damaged parts...

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CONTRACT PACKAGING

CONTRACT PACKAGING

Catalog excerpts

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