ISO Class 8 clean room manufactured packaging materials designed for sterile medical device applications. These materials maintain product sterility and protection throughout distribution.
Manufactured by
PLITEK LLC
Prospect Heights, IL, United States
PLITEK® has been a leader in clean room die cutting and precision converting for over 50 years. Through our expansive converting capabilities, we manufacture products and components from thin gauge films, plastics, foams, and adhesive tapes for POC diagnostic devices, lateral flow assays, microfluidics, and wearable sensors. Our unique combination of engineering expertise, materials science, prototyping capabilities, class 8 clean rooms, and vertically integrated manufacturing allow us to provide innovative solutions for complex medical converting requirements. PLITEK® is certified to ISO 9001:2015 and ISO 13485:2016 standards and is compliant with FDA, cGMP, and ITAR regulations. We are currently in the process of implementing and achieving compliance with Health Canada regulations. PLITEK® s CONVERTING CAPABILITIES: Precision Die Cutting Laser Cutting Clean Room Film Extrusion and advanced precision coating services.
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RoweMed AG - Medical 4 Life · Germany
ISO 7 cleanroom packaging services for sterile medical devices. Includes labeling, traceability documentation, and validated sterilization integration for single-use products.
CPM Precision GmbH · Germany
Cleanroom packaging and sterilization services for medical device components performed in ISO-classified clean rooms. Ensures sterility maintenance and regulatory compliance for implantable and surgical device components.
STERIVIC MEDICAL CO.,LTD · China
Specialized packaging materials meeting ISO and international standards for medical device sterilization. Materials are designed to maintain sterility and protect medical instruments during storage and transport.
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