Cleanroom Maintenance and Industry Standards (GMP & ISO Compliance)

In the first article of this series, we provided insight into the critical role of microfiber wipes in contamination control, explained why microfiber matters, and reviewed some of their benefits. This second installment will focus on cleanroom maintenance and industry standards while discussing key compliance factors for cleanroom wipes.

Cleanroom Maintenance and Industry Standards (GMP & ISO Compliance)

Cleanrooms are classified based on their level of contamination control, typically defined by ISO cleanroom classes (e.g., ISO Class 5, Class 7) or GMP classifications (Grades A, B, C, D). Maintaining these classifications requires strict cleaning protocols, and choosing wiping materials is essential. High-quality cleanroom microfiber wipes are crucial for compliance, as they facilitate effective cleaning and prevent particle shedding.

ISO Cleanroom Classes: ISO classifies cleanrooms based on the maximum particle count per cubic meter. For instance, ISO Class 5 is commonly needed in aseptic filling areas, comparable to GMP Grades A/B, while ISO Classes 7 and 8 are suitable for Grade C/D areas. Microfiber wipes help maintain particle count limits, releasing minimal lint and efficiently removing contamination. Berkshire’s MicroPolx® 1900 wipes are processed in an ISO Class 5 cleanroom, making them suitable for ISO 5–8 environments. More advanced options, like MicroPolx® 2750, are manufactured in an ISO Class 4 facility for use in higher classifications. Selecting the appropriate ISO-compatible wipe is critical to compliance.

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Cleanroom Wipes

MicroPolx® 1900 9″ x 9″ (Pack)

$51.88

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Cleanroom Wipes

MicroPolx® 1900 12″ x 12″ (Pack)

$63.13

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MicroPolx® 2750

MicroPolx® 2750 9″ x 9″ (Pack)

$121.36

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MicroPolx® 2750

MicroPolx® 2750 9″ x 9″ (Case)

$970.85

GMP and Regulatory Expectations: Pharmaceutical and biotech manufacturing must adhere to cGMP (Current Good Manufacturing Practice) regulations, emphasizing cleanliness and control of contamination. Although GMP regulations do not specify particular wipes, they require a documented contamination control strategy. Cleanroom-grade microfiber wipes excel in this area, as they are low linting and reduce the risk of introducing contaminants. Additionally, materials used in Grade A/B zones must be sterile or sanitized. Berkshire offers sterile options, such as the Gamma wipe line, which complies with cGMP standards for critical manufacturing areas.

Key Compliance Factors for Cleanroom Wipes

When selecting wipes for healthcare and pharmaceutical cleanrooms, it is crucial to consider various characteristics that meet ISO class criteria and Good Manufacturing Practice (GMP) standards. The following factors are essential:

1. Low Particle and Fiber Emission: Wipes should be manufactured and packaged to minimize linting, often achieved through sealed-edge knitting and cleanroom laundering. This helps maintain the required particulate levels (ISO class) and prevents product contamination.
2. Low Extractables and Residues: High-purity wipes should be free from excessive residues, including detergents, surfactants, and ionic contaminants. GMP requires the control of contaminants, such as endotoxins and chemicals. Microfiber polyester wipes typically have very low non-volatile residue (NVR) and ion content, especially when laundered in ultra-pure water. This ensures no reactive or interfering substances remain on equipment surfaces after use.
3. Chemical Compatibility: Wipes must be compatible with standard disinfectants and solvents used in the pharmaceutical industry, such as 70% isopropyl alcohol, hydrogen peroxide, and sporicides. Polyester/nylon microfiber is generally resistant to these chemicals and will likely not degrade or shed fibers when saturated. For example, Berkshire’s microfiber wipes are compatible with IPA and other solvents, making them suitable for applying disinfectants or cleaning up solvent spills.
4. Sterility (when required): In Grade A/B aseptic processing areas, wipes often require sterilization. Microfiber wipes can be sterilized through gamma irradiation and are validated to provide a Sterility Assurance Level (SAL) of 10^−6. Using sterile pharmaceutical cleaning wipes ensures compliance with regulations, preventing the introduction of viable organisms during cleaning. Additionally, specialized low-endotoxin wipes with certified endotoxin levels can be employed to avoid pyrogen contamination on critical product contact surfaces.

By aligning wiping products with ISO class and GMP requirements, healthcare and pharmaceutical facilities can ensure their cleaning processes are fully compliant. Cleanroom microfiber wipes meet these standards, being low-lint, ultra-clean, and highly effective at removing contaminants. Therefore, they are crucial in routine cleanroom maintenance and regulatory compliance.