Validation is an integral part of the medical device industry. Therefore, the raw materials intended for specific medical packaging, which are manufactured in a clean room, have standard approvals from both the F.D.A. (US Food and Drug Administration) and the E.E.C (Joint EU Health Authority). These raw materials are also manufactured in clean rooms and under particularly stringent quality control.
We produce small batches for validation with the help of a professional team of staff trained in the production of structured batches according to ISO CE FDA approved processes.
Assistance in writing procedures for work processes and regulatory examinations and everything according to the product.
Packaging audits Quality Check for Packaging
Clean Pak is certified to ISO 9001 and adheres to the highest international standards in work practices, manufacturing and quality standards. The company’s specialization in manufacturing markets where there is strict supervision, such as the food and pharmaceutical markets, ensures close supervision and strict quality control throughout all development and production phases, while maintaining a clean production line. In addition, additional individual-sample quality control is carried out on production lines as needed.
The company’s products are manufactured from a variety of raw materials such as: PVC, PET, PETG, PS, APET, ABS and anti-static raw materials, which have been subjected to quality tests in research laboratories in Israel and around the world, and approved by the Ministry of Health and the Institute of Standards and by a number of standard institutions. Other international, including BRC and ACCAP.
The constant supervision, alongside the accumulated skill and experience in the company, ensures accurate production of high quality, advanced design enclosures that maintain an equal polymer dispersion in the product body and a smooth and uniform finish.