One year GMP Annex 1: Expert Interviews Part 1

What is going well, where are the challenges?

One year ago, in August 2023, the changes to GMP Annex 1 came into effect and became a new requirement for everyone, with the resulting responsibilities and challenges.

What requirements does GMP Annex 1 place on cleanroom garments in the various cleanroom classes?

"The ‘new’ GMP Annex 1 places more emphasis on cleanroom garments. Firstly, in ISO class A/B STERILE, it defines that sterile clothing and headwear must completely cover the face and hair. In addition, a sterile face mask and protective goggles are required to form a complete barrier. This change is certainly challenging for people who work in cleanrooms differently.

I see another challenge in the prescribed qualification of cleanroom gowning systems. Qualification here means providing proof that the cleanroom garments used guarantee the defined performance characteristics at all times during the defined number of decontamination cycles. It also means defining the maximum wearing time per use, always based on the specific cleanroom conditions and contamination risks.

For Class C, the main requirements are appropriate undergarments and socks, as well as changing in appropriate areas to avoid contamination at this stage.

These updated requirements are part of the contamination control strategy. It centralises all measures to prevent contamination in sterile, pharmaceutical production and is to be implemented throughout the facility."

How does the guideline affect our customers' garment concepts in practice? Is the implementation equally feasible for everyone?

"My experience working with our customers shows that there are big differences: Depending on how long the companies have been familiarising themselves with GMP Annex 1 and what resources are available to incorporate the updated guideline into existing processes. This is often related to the size of the company. When it comes to clothing, it's not just about the right choice of cleanroom products – the GMP Annex 1 now also anchors the professional decontamination of clothing."

Can you give examples of challenges that companies face when it comes to compliance?

"One example at product level are sterile cleanroom safety goggles, which are new and also need to be qualified. In addition to the challenge of selecting suitable safety eyewear and defining how long the life cycle is, we must admit that it is of course more comfortable to work without safety eyewear than to wear it for 4-8 hours every working day. Wearing corrective eyewear can also cause additional discomfort if the safety eyewear is unsuitable and subsequently affect the work routine. However, cleanroom goggles serve as an important barrier to prevent contamination from human skin flakes, particles and droplets in cleanroom processes and on products. In order to increase employee acceptance, we at CWS Cleanrooms advise our customers on whether directly or indirectly ventilated safety goggles are best suited, for example, and work together to find the best fit. 

To support our customers with qualification, we have conducted a validation study and our cleanroom goggles are equipped with RFID chip technology that tracks the specified life cycle. Our validated decontamination processes ensure maximum safety and comfort, cycle after cycle.

In order to qualify entire cleanroom garment systems, we are currently conducting several garment studies with our customers and partners. These include contamination analyses under comparably real cleanroom conditions based on IEST RP CC 003 4 as well as various material tests, which are carried out in accredited institutes. Organising this alongside the actual work in the cleanroom is a considerable burden. That is why we have created an infrastructure in which our customers can drop off the items as usual and we take care of the other measures to achieve qualification of the garments."

What strategies or approaches do you recommend to ensure continuous compliance with the guidelines for garment concepts?

"In my eyes, it is important to first look at which elements do not currently comply with the requirements for a contamination control strategy in accordance with GMP Annex 1. As I said, compliance does not always have to mean tightening up. It is about recognising contamination risks and defining measures to prevent contamination. The documentation of the measures is proof of the implementation of a contamination control strategy. Monitoring shows us whether the defined measures are effective according to the particle limits of ISO and GMP classes, or which measures should be re-evaluated in the further course."

What do you observe in the cleanroom laundries of CWS Cleanrooms?

"With our qualified process, we already ensure that clothing and equipment are not damaged and/or contaminated by fibres or particles during the repeated washing process.

To this end, we have established the following processes, among others, which are relevant to GMP Annex 1:

• Cleanrooms certified according to ISO14644, validated washing procedures and packaging processes according to cleanliness classes ISO 5 and higher
• An incoming goods inspection is always carried out beforehand
• After each wash cycle and before packaging, all items are visually inspected for damage and visual cleanliness 
• Compliance with the particle limit in accordance with ISO class 5 is carried out on random samples for each individual wash batch

Our measures ensure that our customers are always adequately equipped in accordance with the prescribed ISO classes to operate in compliance with GMP Annex 1 and are part of our customers' contamination control strategy. 

We also offer professional pick-up, delivery and much more. So we are much more than just a cleanroom laundry, we are a full-service provider in our industry.”

Thank you, Catrin, for your assessment & sharing your experiences!

Do you have challenges in your cleanroom processes? Then don't hesitate, our Xperts will be happy to advise you.