Avoid contamination

Plug&Pack Packaging System

cleantray = Protective film for lyophilization trays

cleanzip = cleanroom-compatible resealable bags

In the supply chains of medical devices, plastic packaging plays a central role in ensuring product quality. After all, it is about avoiding contamination of sensitive products. Microbiological and particulate contamination must be eliminated to protect the product and ensure patient safety. When the plastic packaging used is cleanroom-compatible and produced in accordance with GMP standards, it can make an important contribution.

To prevent damage and contamination of pharmaceutical or medical technology products during handling and transportation, they must be appropriately packaged. In many cases, flexible plastic packaging is used, such as pouches, tubes, or films. However, medical devices generally need to be manufactured in a controlled production environment. These specific requirements are described, for example, in the GMP guidelines of the pharmaceutical industry or in regulations concerning medical devices. Usually, cleanrooms operated according to ISO 14644 are used to meet these high standards of hygiene and cleanliness. Therefore, the GMP guidelines treat packaging materials on the same qualitative level as raw materials when chapter 5 states: “... The selection, qualification, approval, and maintenance of suppliers of primary and printed packaging materials should be given as much attention as that of raw material suppliers...” This is understandable considering that primary packaging made of plastic comes into direct contact with the product. The requirements are especially relevant for pharmaceuticals, medical technology, life sciences, and healthcare. The products manufactured there require continuous quality monitoring. This applies to active pharmaceutical ingredients (API) as well as to plastic components, implants, instruments, pumps, tubes, and more. Many of these products are used in diagnostic applications, test kits, or laboratories.

Avoiding contamination risks

The goal is to avoid contamination risks for the product as well as for the manufacturing process throughout the entire supply chain of product development. And this naturally applies at all stages of the supply chain – from the active ingredient manufacturer to component and assembly manufacturers to service providers, e.g., filling, contract packaging, sterilization. The packaging used must be produced under the same quality and hygiene standards as the product to be packaged. It would be fatal if the packaging, which is supposed to protect the product, posed a contamination risk because, for example, it is contaminated, exhibits a critical bio-burden, or causes product property impairments through migration processes between the packaging and the product. Consider the importance of stability or extractables/leachables studies here. These issues must be thoroughly evaluated in a systematic risk analysis for primary packaging materials to identify and exclude potential contamination risks in packaging specifications.

The medium-sized company Strubl Kunststoffverpackungen, based in Wendelstein near Nuremberg, has addressed these special requirements and has been producing cleanroom packaging for over 10 years that meets the highest quality standards. The pouches and films are produced in a professional cleanroom environment qualified according to ISO 14644 and compliant with the GMP requirements of pharmaceutical customers. Validation of products and processes, hygiene management, traceability are standard, as well as complete documentation and specifications with test certificates and customer audit procedures. The special aspect is that all products are manufactured customer-specifically, thus fully meeting individual customer requirements.

Innovative solutions for cleanroom packaging

Customers can benefit from the company's innovative strength. For example, antistatic materials conforming to Ph-Eur have been developed. This is especially important in applications where packaging of powders is involved. Another example: for freeze-drying processes (lyophilization), Strubl has developed a precisely fitting “Cleantray.” The Cleantray 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 eliminate the need for elaborate cleaning processes of the trays, leading to improved equipment availability and increased efficiency.

The development of Cleanzip cleanroom resealable bags has been highly successful. These zip-closure resealable bags are used in laboratory applications, sample collection, sample archiving, intermediate packaging, and primary packaging of components and parts, e.g., for diagnostic products. When sterilization barrier systems according to ISO 11607 are required, it is important to conduct packaging validation with appropriate testing. Strubl products can be sterilized by gamma irradiation. Strubl supports packaging development and can provide the necessary validation documents for the packaging bags. Other clever solutions include cleanroom double bags or bags with “easy-open” opening aids.

Plug & Pack systems for automating packaging processes

Packaging in the cleanroom is often still manual and always carries a contamination risk due to handling activities. The flexible Plug & Pack system allows cleanroom bags to be filled, labeled, printed, and sealed semi-automatically or fully automatically. The system can be integrated into an Industry 4.0 environment, thus supporting the digitalization process in the cleanroom.

To further strengthen the competitive position, various investments have been initiated. For example, new systems are being installed for the production of tube films. Simultaneously, requirements for recyclable packaging and labeling regulations are being met.