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Manufacturers licensed to sell pharmaceuticals and medical devices in the EU and PIC/S member countries must comply with Annex 1, regardless of country of origin.
While the FDA has not revised its standards to reflect the same requirements as Annex 1, FDA inspectors may inspect facilities according to Annex 1 rules if the product is licensed for the EU or PIC/S countries.
This case study series explores the significance of addressing microbial contamination and ensuring compliance with regulatory standards, particularly focusing on the role of cleanroom socks in maintaining cleanliness and adherence to protocols.
The three contaminant types that need to be managed in a life science cleanroom are particulates, bacteria, and endotoxins.
Sterile, medical-grade gloves may contain multiple contamination types because:
This case study discusses the critical importance of managing particulates, bacteria, and endotoxins in a life science cleanroom environment, and underscores the necessity of addressing potential sources of contamination associated with sterile, medical-grade gloves with real-world practices.
Cleanrooms have evolved due to changing industry needs and technology. In 1962, Federal Standard 209 was established to distinguish cleanrooms from regular "clean rooms."
This technical paper series provides a comprehensive overview of the entities such as;
A Class 10 cleanroom garment or a Class 100 wiper or glove does not exist.
Manufacturers asserting a product is certified to a broad cleanroom standard is an overgeneralization that was the result of a marketing fad in the 1990s.
This technical paper explains how controlled environments should develop criteria for critical reusable and single-use materials in line with IEST Recommended Practices.
Authored by Jan Eudy for Valutek.
Engineered For Semiconductor & Advanced Microelectronics Applications
Constructed from synthetic nitrile polymer containing no Titanium Dioxide (TiO2) pigment.
In order to develop an additive-free nitrile material, Valutek has removed all color pigment — the source of a known contaminant, Titanium Dioxide — from this specific formulation.
The result is a cleaner, translucent glove with enhanced performance and operator comfort.
Recommended for use in a cleanroom Class 1-10 (ISO 3-4) critical environment.
Selecting the right products to use in your critical environment can be challenging.
Valutek has simplified the process and developed three product families: NanoTek, MicroTek, and MacroTek.
These product families are designed to guarantee the consistent and stable operation of your cleanroom processes.