We work with leading manufacturers to provide a comprehensive range of products, training and safety solutions for the Pharmaceutical Sector.
Do you understand the changes to the GMP (Good Manufacturing Practices) Annex 1 revision of August 2022? The guide from DuPont below covers the sterility issues found with reusable cleanroom garments and benefits of single-use clothing.
We work with industry leading manufacturers such as 3M, DuPont, Ansell, to provide a full range of PPE for all pharmaceutical applications – R&D, manufacturing, Ex-Zones, and cleanrooms.
Read the whitepapers from 3M & DuPont to understand the protection offered for every application.
Wise Safety Ltd are distributors of Dry Box gloves & sleeves manufactured by the French company Piercan.
For over 10 years, PIERCAN has offered its customers decontaminated and/or sterilised gloves. This service is intended in particular for pharmacy environments (pharmaceutical laboratories, hospitals etc.) but it may also be for industries
in which an extremely high level of cleanliness is now absolutely vital (space, military, research etc.). Please do not hesitate to request the documentation about this service.
The DuPont IsoClean clean-processed and sterile garment range and accessories are specially processed to minimise particle shedding, then folded to aid in aseptic donning and packed in an ISO Class 4 cleanroom. The box quantity is packed in a cardboard box with two polyethylene liners. Sterility is achieved by gamma irradiation. Radiation dosage is validated in accordance with ISO 11137 for a Sterility Assurance Level (SAL) of 10⁻⁶.
DuPont have conducted a study into the contamination risks associated with reusable cleanroom clothing compared to the Sterile IsoClean range. Key points include:
The validation of reusable cleanroom garments is more complex than single-use cleanroom garments.
These all influence the quality of reusable cleanroom garments. The influence of these factors must be validated throughout the entire life cycle.
In addition, not only the garment supplier must be qualified, but also the cleanroom laundry, sterilization facilities and repair service.
The Helmke Drum test aims to quantify the number of particles “dislodged from a garment through the application of mechanical energy under dry conditions as a means of simulating particle shedding from the surface of the garment.” by rotating them in a drum. This is the most common particle shedding test.
All reusable and single-use garments go through this test. DuPont include the certificate in each box and test a garment from every batch.
However the new GMP Annex 1 states: “7.12 Clothing should be chosen to limit shedding due to operators’ movement.” which the Helmke Drum test doesn’t consider.
The Body box test IEST-RP-CC003.4 is the only test method of particle shedding when a garment is being worn. In this test, a fully garbed test subject conducts a series of movements inside a box supplied with HEPA-filtered air. Body box testing not only measures particle generation from the garment, but also can indicate its function as a particle barrier.
Take time to check your cleanroom garments, which test method is used? Do they limit shedding caused by operator movement? Does your QRM consider these factors?
Below is a selection of the products that we supplying into businesses in the Pharmaceutical industry.
From your cleanrooms & laboratories, down to warehouse & storage, we have solutions for all your workers.
Check out the other categories on our website, or speak to our team to discuss your company’s needs – 0151 495 5650
