GMP Cleanroom Packaging

Typical use of foil bags in a cleanroom production at HPT, D-Neuhaus.

Example: Cleanroom bag for pharmaceutical glass

Example: Cleanroom bag for plastic parts

Example: Cleanroom film for implants

Cleanroom production ISO 7/8 for the manufacturing of cleanroom packaging at STRUBL KG.

Employee qualification and GMP culture are the prerequisites for impeccable quality.

Cleanroom bags and films from STRUBL are the effective solution for protection against contamination in the cleanroom supply chain. Packaging as a contamination risk? Yes, of course – and precisely when the packaging is produced under lower hygiene and cleanroom conditions than the product being packaged.

Cleanroom production in pharmaceuticals and medical technology – this has now become standard when it comes to meeting the high requirements for cleanliness and hygiene. 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 (films, hoses, bags) is used 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 is used. From the perspective of the respective product, the film packaging always attains the status of a “primary packaging material.”

Risk factors in packaging

These film packagings come into direct contact with the product, which can result in significant risks:

1. Raw material risks: migration between packaging and product, surface contamination, raw material conformity and approvals

2. Process risks: particle emission leading to contamination of the cleanroom or GMP environment, e.g., during unpacking and repacking

3. Logistics risks: insertion and removal, cleanroom cascade determines the re-packaging, “packaging of the packaging”

4. Product risks: technical parameters such as seam strength, seam tightness, weldability

The entire cleanroom supply chain must face these risks. The solution is obvious: the packaging used must meet the same quality and hygiene standards as the product itself.

Risk recognized – danger eliminated?

It's not that simple, because the packaging producer must be capable of producing GMP- or cleanroom-compliant packaging. A packaging with standard qualities can no longer be sensibly used here. After all, no “normal” spare parts or accessories are being packaged, but medical components and pharmaceutical products. Quality, as is well known, must be produced and cannot be tested. Therefore, the packaging manufacturer must first establish an adequate production system. This is a complex organizational development process.

STRUBL KG Kunststoffverpackungen is the specialist for cleanroom packaging. As a competent partner, tailored solutions are developed with customers: in addition to flat and (semi)tubular films, mainly bags and sacks, side-fold bags, block-bottom bags, multi-chamber, double bags, and sterilization bags. The products are manufactured in a GMP-compliant cleanroom production facility using state-of-the-art technology. Based on an ISO 9001 quality management system, a professional GMP system has been implemented. This supports all processes. This means: specification, monitoring, hygiene management, cleaning concepts, risk analysis, traceability, documentation, validation, and more. With over 60 years of experience, the medium-sized family business 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. The products are used both as primary and secondary packaging materials. Many satisfied customers confirm the consistently high quality level.

A particularly interesting solution for insertion and removal in multi-stage cleanroom zone concepts is the use of so-called sack systems. STRUBL supplies nested sack systems. At the customer’s site, these are opened, and the inner bag is filled with products. Then, the individual bags are sealed separately and can later be removed sequentially in the cleanroom process, similar to a “onion skin model.” This eliminates the complicated handling during filling in the cleanroom.

GMP culture as a learning process

Throughout the entire production process—from order acceptance through manufacturing to shipping—GMP principles are applied by implementing DIN 15378 (primary packaging for pharmaceuticals) and DIN 15593 (hygiene management in food packaging manufacturing). The GMP guidelines define the essential requirements for product and process. Implementing a GMP-compliant organization is an ongoing learning process for the company and all involved employees. It is important to recognize that there is no “one best way,” but rather a company-specific GMP system must be developed that aligns product and process requirements with the customer’s quality and GMP/cleanroom standards. GMP begins primarily in the minds of the employees. Only when employees behave in a GMP-compliant manner in their daily work can the system sustainably produce the necessary quality. This is sometimes a lengthy process, as it involves unlearning ingrained behaviors and changing routines, such as insertion and hand hygiene, documentation, creating so-called “batch records,” and also the intensity of quality control and documentation, which far exceeds the usual ISO 9001 requirements.

STRUBL has successfully embarked on this demanding path; there is no end in sight. “It’s like a staircase that never stops,” comments Georg Kurz, plant manager at STRUBL at the Nabburg location, “once you reach a step, the next challenges already await.”