Cleanroom packaging and cleanroom supply chain

Typischer Einsatz von Folienbeuteln in einer Reinraumproduktion bei der Gerresheimer AG. / Typical application of bags in a cleanroom production at Gerresheimer AG.

Abbildung 1

Figure 1

Reinraumproduktion ISO 7/8 zur Herstellung von Reinraumverpackungen bei der STRUBL KG. / STRUBL cleanroom production ISO 7 for manufacturing of cleanroom packaging

Mitarbeiterqualifikation und GMP-Kultur sind die Voraussatzung für einwandfreie Qualität. / Qualification and training provide highest product quality.

Beispiel: Reinraumbeutel für Kunststoffprodukte. / Sample: Cleanroom bag for medical plastic parts.

Beispiel: Reinraumfolie z.B. für Instrumente. / Sample: Cleanroom film for instruments.

Cleanroom bags and films produced by STRUBL are an effective solution to protect against contamination at all steps of the cleanroom supply chain. Does packaging cause contamination risks ? Sure – if the packaging material has been produced under low-level terms of hygiene- and cleanroom conditions. Packaging and Product need to be produced in similar quality conditions. 

Manufacturing and packing under cleanroom conditions became a standard process in the pharmaceutical and medical-device industry. That’s the only way to achieve the extrem requirements concerning hygiene  and cleanliness. This applies for pharmaceutical and chemical substances  as well as for plastic components, implants, pumps, tubes, bottles, caps, plastic or glass primary packaging.  Before leaving the cleanroom areas, the products need to be packed carefully to protect them against damage and contamination during transport and handling. For this operation plastic films, tubes and bags are the mainly used packaging materials all over the cleanroom supplychain. 

Risk of packaging  

Plastic packaging is used all over the cleanroom supply chain. All companies being part of this supply chain have to deal with potential packaging risks. This indicates, that on every supply chain’s level packing materials need to reach a primary packaging quality status. (see figure 1)

These plastic packaging materials are in direct contact with the product which implies significant risks, such as: 

1. raw material risks

- conformity of raw materials in reference to the application has to be checked

- migration between packaging material and product has to be eliminated absolutely, because this may change important product quality properties 

2. process-risks

- to contaminate cleanroom production areas and

- to contaminate cleanroom products by low-quality packaging materials 

3. logistic-risiks

- contamination during handling and transport 

- locking in and out into controlled cleanroom areas

The only way to handle and eliminate these risks is to use GMP-qualified packaging materials. This implies a packaging manufacturer with cleanroom facilities and GMP-qualified production systems. But the most important key factor is an intense cooperation and networking between customer and packaging manufacturer. 

Specification of cleanroom packaging 

The basic principle for packaging specification: packaging materials used in cleanrooms need to achieve the same quality requirement as the final cleanroom product. 

1. The final product’s quality level specifies the quality level for the packaging materials all over the supply chain.
2. The customer's cleanroom level specifies the quality level for the packaging supplier’s manufacturing process.
3. The only way to handle and eliminate these risks is to use GMP-qualified packaging materials.
4. An absolut clean and controlled production area is the basic condition for cleanroom applicable packaging materials.
5. If these principles are implemented the customer is able to verify that the product contacting packaging supports the product quality.

STRUBL cleanroom packaging solutions 

STRUBL Packaging is a German specialist for cleanroom packaging. The company develops and supplies blown film and flat film, bags, side gusseted bags, bag systems (double / triple) and sterilization bags for cleanroom products. These packaging products are produced in a cleanroom production with an integrated high professional GMP-system supported by ISO 9001 quality management systems based on DIN 15378 (primary packaging materials for medicinal products) and DIN 15593 (management of hygiene in the production of packaging for food-stuffs). These systems specify the main demands on product and process such as order fulfillment, operations and logistics. This implies: cleanroom production, hygiene management, bio-burden-monitoring, pest control, risk-analysis, traceability, documentation and specification, validation and qualification. 

Cleanroom packaging materials by STRUBL are used by a lot of well named brands and companies in the pharmaceutical markets as well as in medical device, chemical, electronics, automotive or food industry. These companies use STRUBL cleanroom packaging as primary or secondary packaging on a high quality level.

GMP-culture is a learning process 

To install a GMP-organization is comparable with a company wide learning process. Finally, there exists no “one-best-way”, every company has to design a specific GMP-system to harmonize own and customers product-, process- and quality requirements. Only a longterm teamwork between customer and supplier will be successful for both partners.