cleantray – cleanzip – cleanpackaging Cleanroom packaging to protect against contamination

Examples of cleanroom packaging: films and bags

cleanzip = cleanroom-compatible resealable bags

Advantages of the envelope system

Production and packaging in cleanrooms are always highly relevant topics. The product packaging must preserve product and process quality. Primary packaging for products in pharmaceuticals and medical technology must meet the highest quality standards. Hygiene and particulate cleanliness are fundamental prerequisites for the use of plastic packaging as primary containers. STRUBL Plastic Packaging has perfect conditions for this with an ISO 14644 cleanroom production facility.

Cleanroom production based on the ISO 14644 series is a common standard in industries where products must meet the highest requirements for cleanliness and hygiene. This naturally applies especially to the pharmaceutical, medical technology, life sciences, and healthcare sectors. The manufactured products require continuous quality control. This applies to active pharmaceutical ingredients (APIs) as well as to plastic components, implants, instruments, pumps, hoses, and more. Many of these products are used in diagnostic applications, test kits, laboratories.

To prevent damage and contamination during handling and transport, these products must be packaged before leaving the cleanroom. Plastic packaging in cleanroom quality is specifically designed for this purpose. At all stages of the cleanroom supply chain – from the active ingredient manufacturer through component and assembly manufacturers to packaging and service partners – film packaging in the form of bags, pouches, cuttings, films, hoses are used. Plastic packaging is always a “primary packaging” and must meet the highest quality standards.

Cleanroom packaging is the solution against contamination risks

Contamination risks must be avoided throughout the entire product creation supply chain. This can only be achieved if the packaging used is produced under the same quality and hygiene standards as the product being packaged. Particular attention should be paid to specific risk factors such as:

- Raw material risks: migration between packaging and product,
- Process risks: particle emission leading to contamination of the cleanroom or GMP environment,
- Logistics risks: cleanroom pallet determines repackaging, “packaging of the packaging”,
- Product risks: technical parameters such as seam strength, seam tightness, weldability

cleantray – for contamination-free lyophilization

The cleantray developed by STRUBL is an intelligent solution for use in freeze-drying processes. The PE tray serves as a base for the trays on which the products undergo the freeze-drying process. This can help avoid elaborate cleaning processes of the trays.

cleanzip – sterile zip-lock bags in cleanroom quality

Another development from STRUBL is cleanroom-compatible zip-lock bags. These resealable bags with a zip closure are a standard packaging material for countless applications but have not previously been available in cleanroom quality. The range of applications for cleanzip zip-lock bags extends from laboratory use, sample collection, sample archiving, intermediate packaging, to primary packaging of components and parts. The cleanzip zip-lock bags are manufactured in a GMP-compliant environment, meeting the high requirements of pharmaceutical and/or medical device standards, such as those specified in the EU Good Manufacturing Practice (GMP) guidelines.