As a manufacturer of medical devices and pharmaceutical products, SteriPack is responsible for packaging compliance with FDA and ISO requirements. This applies to product protection but above all to the health of practitioners and patients.
Many modern technologies and machines allow the use and mixing of various polymers to achieve the appropriate functionality whilst maintaining a sterile barrier and thus safety and compliance with regulations. There is a large importance on seal integrity and how the packaging reacts to external conditions; it must be strong enough to maintain its integrity and weak enough to be opened by medical personnel.
SteriPack offers packaging services in ISO Class 7 and ISO Class 8 clean room accredited to ISO 13485 standards. SteriPack prides itself on constantly monitoring all processes to ensure the correct parameters have been selected, to allow repeatability of manufactured goods and to guarantee that end products are of the highest quality. Continuous inspection of the production line and documentation provides evidence of product compliance with customer and regulatory requirements.
Our packaging scope range includes:
- Pouching (four side seal)
- Soft blisters form, fill and seal packaging
- Rigid blisters form, fill and seal packaging
- Labelling and printing
- Secondary and tertiary packaging
- Visual inspection
- Vision control system