Andrew Cole, Managing Director, Micronclean India Pvt Ltd
Drawing on almost four decades of experience, Andrew Cole, Managing Director, Micronclean India Pvt Ltd deconstructs the concept of clean room laundry, its role in the pharma sector, regulatory standards for pharma operator uniforms, and the benefits of outsourcing their cleaning and decontamination.
In simple terms
The manufacture of pharmaceuticals and other bio-technical products within manufacturing cleanrooms requires the use of specialised garments that prevent contamination of the product by the person working in the cleanroom. The specialised garments must be processed in accordance with strict parameters in controlled environments to provide the correct level of decontamination, drying and sterility so that when the garment is returned to the customer, it is ready for immediate use.
In many ways it is possible to think of a cleanroom laundry as a manufacturing cleanroom that takes in soiled/contaminated garments and returns them ready for immediate use.
Controlled environment
Our facility in Bangalore is a modern GMP Grade B (ISO Class 5) cleanroom which is subject to the controls you would normally expect, such as routine environmental monitoring (microbiological and particulate). This ensures that the garments are processed and packed in conditions that are equivalent to those the garment would experience in use.
Garments supplied from the cleanroom laundry are decontaminated and sterilised using validated processes to achieve a garment that is sterile and has low levels of particulate contamination (ASTM F51 Class A / IEST RP CC 003 Category 1).
In addition, as a barrier cleanroom laundry, each garment is tracked (using an RFID tag sewn into the garment) into a specific processing batch so that we have full traceability of its visual inspection, repairs history (if allowed by the customer), thermal disinfection, drying and sterilisation cycle, which is used for parametric release of the garment against the validated procedures.
Consequences of laxity
Workwear that is not adequately decontaminated and sterilised is a direct risk of contamination within a cleanroom. In addition, workwear that does not create an adequate barrier to contain contamination released by an operator is an indirect risk of contamination within a cleanroom.
In some documented cases, poor cleanroom workwear has resulted in unacceptable contamination of pharmaceutical batches worth millions of dollars, which ultimately have had to be destroyed at huge cost to the pharmaceutical business. In addition to the direct costs, there have also been reputational and consequential damages from either supply shortage in the marketplace or having to withdraw a product from the marketplace.
Regulatory standards
The latest regulatory change has been the introduction of the revised version of EU GMP Annex 1 covering the Manufacture of Sterile Medicinal Products. This guideline is being adapted throughout the EU and by the MHRA in the UK. In the US, the FDA is not formally enforcing Annex 1 but is expected to enforce similar requirements. The aim of all the regulators is to enforce an overall contamination control strategy (CCS).
In terms of garments, Annex 1 states that all cleanroom clothing and its quality should be appropriate for the process being undertaken, the grade of cleanroom and should always protect the product from contamination. For reusable cleanroom garments, Annex 1 further states that these garments should undergo qualification studies. These studies should determine the life of the garments, depending on their processing and use cycles.
Additionally, Annex 1 states that any garment testing should go beyond visual inspection, as this might not detect all the sources of damage that could affect the garment’s performance within the cleanroom and so potentially damage the product being manufactured.
As a company, we can provide batch process data that proves that the decontamination and sterilisation processes have been correctly adhered to. We have also invested significant time and money to qualify cleanroom workwear to determine a maximum garment life, based not only on the use cycle that the garment will see within your cleanroom, but also on the fundamental garment/fabric testing results which proves that the intrinsic garment properties are not compromised during the processing of the garment over its expected life.
Why outsource?
All reputable pharma manufacturers will recognise the need for a cleanroom laundry for the supply of cleanroom garments to their operators. Some will opt to do this in-house with their own on-premise laundry and some will choose to subcontract to a third-party specialist supplier like us.
Not only can we supply the garments in a sterile, ready-to-wear condition but we can also advise on the correct garment to use, gowning techniques etc. and help to manage garment supply for quality assurance and cost efficiency. In this way, we support your contamination control strategy – a fundamental requirement of your GMP certification – while also helping to manage your costs.
Cost vs benefit
In the Indian market, we do see a lot of cost sensitivity. However, we have encountered a few areas where the true costs are not known. For instance, where cleanroom garments are not tracked correctly, no-one knows whether the garment achieves its claimed life of say 100 cycles, and so the cost of that garment is not really known. This lack of garment tracking could also affect the user’s ability to conform to the requirements of Annex 1 or another regulatory framework. The systems we use give absolute clarity on garment performance through life and the true costs of ownership.
We also allow companies to focus on pharmaceutical manufacturing without having to divert time, attention and capital to setting up and then running an on-premise laundry, with all the logistics that entails, employing additional staff and the capital cost of the laundry equipment.
1 comment
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