"bag in bag" for protection against contamination

Example: Cleanroom bag for plastic parts

Advantages of the pouch system

Cleanroom production for cleanroom bags at STRUBL

How can high-quality products produced in a cleanroom environment be packaged and protected to be contamination-free and safely introduced and removed in the complex logistics process within the cleanroom supply chain? "BAG-IN-BAG" is an optimal solution for this purpose.

Cleanroom production is standard when it comes to meeting the highest requirements for cleanliness and hygiene. This is especially true for the pharmaceutical, medical technology, life sciences, and healthcare industries. The products manufactured in these sectors require continuous quality monitoring. This applies to active ingredients as well as to plastic components, implants, instruments, pumps, hoses, and more. To prevent damage and contamination during handling and transport, these products must be packaged before leaving the cleanroom. Plastic packaging materials (films, hoses, bags) are used for this purpose. At all stages of the cleanroom supply chain – from active ingredient manufacturers through component and assembly producers to packaging and service partners – film packaging is employed.

Special logistical challenges must be considered in cleanroom processes: cleanroom production areas are enclosed environments. Personnel are only allowed to enter via specialized sluice systems. The same applies to materials and raw materials. To put it simply: everything that must enter the cleanroom must be contamination-free packaged so as not to compromise the cleanroom process quality. Conversely, the same applies: everything that must exit the cleanroom must be packaged to prevent contaminating the product’s cleanroom quality level. It is not uncommon for different cleanroom zones with increasing quality levels to be traversed, with multiple entries into each zone. This requires packaging like an onion skin model: in each material sluice, the outer packaging is removed until the product can be further processed in the final cleanroom stage, e.g., in an assembly.

In practice, this problem is solved by multiple packaging of products after production. However, this process is complex. Once packaged, the product is often repackaged into another package, sometimes multiple times (2- or 3-fold). Handling becomes complicated, especially when dealing with heavier packages or sensitive components that are, for example, pressure-sensitive and can be easily damaged.

An efficient solution is offered by a "bag-in-bag" packaging system. This is a bag system in which multiple bags are nested inside each other. The advantage is that with just one packaging process, primary, secondary, and possibly tertiary packaging can be completed. Besides the significant time savings in the packaging process, the main benefit is the reduced risk of damaging the products during handling. The advantages of bag-in-bag systems lie in simplified handling during application and filling. The less handling required in cleanroom production, the better. Because every activity in the cleanroom generates unwanted turbulence.

The bag-in-bag systems can be customized to customer specifications. Customers can adapt the bag system precisely to their requirements using a modular system. Special attention must be paid to the material properties, as primary packaging materials are directly in contact with the product and unwanted contamination can occur through migration processes. STRUBL offers various solutions for this problem and can also process raw materials compliant with pharmacopoeia standards (EP / USP) if needed.

STRUBL is a specialist in cleanroom packaging and "bag-in-bag" packaging systems. All cleanroom packaging is manufactured individually according to customer specifications, of course, in a GMP-compliant cleanroom production system. This guarantees the highest quality. This means: specification, monitoring, hygiene management, traceability, documentation, validation, and more. With over 60 years of experience, the family-owned medium-sized company supplies these cleanroom packaging solutions to renowned manufacturers in the pharmaceutical and medical technology industries, as well as companies in the fields of chemistry, automotive, food, and microelectronics.