Choosing the Ideal Cleanroom Wipes for Pharmaceutical Applications

As a new lab member in the pharmaceutical industry, you are still learning the cleanroom processes. To better understand how to choose the right cleanroom wipes, you have a detailed conversation with an experienced product manager. This discussion will give you clearer insights into contamination control requirements in cleanrooms and how to choose suitable wipes.

New Lab Member: How should we choose the right cleanroom wipes in the pharmaceutical industry?

Product Manager: Great question. First, in the pharmaceutical industry, production environments are divided into controlled areas and critical areas. Controlled areas are classified as ISO 8, where tasks such as handling drug containers, packaging, and labeling take place. Critical areas are classified as ISO 5, where sterilization and disinfection are conducted. The contamination control requirements are much stricter in critical areas, so the standards for choosing wipes are also higher.

New Lab Member: Why is contamination control so critical in these areas?

Product Manager: Many pharmaceutical and biotech products cannot undergo terminal sterilization after production. For instance, they cannot be exposed to steam or radiation sterilants. Therefore, to ensure the final product is sterile, the production environment itself must be completely sterile, avoiding any microbial or particle contamination.

New Lab Member: How do we check if the environment is sterile?

Product Manager: One method is the aseptic media fill test. This involves filling sterile containers with a microbial growth medium to simulate product filling. The process is conducted annually for each filling line, with at least 3,000 units tested each time. The FDA allows up to one contaminated container out of 1,000 tested media-filled containers.

New Lab Member: What are the specific requirements for wipes used in cleanrooms?

Product Manager: Wipes used in sterile environments must be sterile, with low levels of endotoxins and extractable particles. They need to be highly absorbent, durable, and able to work well with disinfectants and cleaning agents. For example, sterile wipes are typically used with water-based disinfectants, such as sodium hypochlorite, quaternary ammonium compounds, or hydrogen peroxide. The larger the volume of disinfectant used, the better it is for eliminating active microbes on surfaces.

New Lab Member: Can wipes remove all residues after cleaning?

Product Manager: In non-critical areas, it's sometimes acceptable to leave small amounts of non-volatile residues on surfaces, as long as they have been disinfected and are sterile. However, just because a surface is clean doesn't necessarily mean it's sterile, and vice versa.

New Lab Member: Do you have any recommendations for wipe materials?

Product Manager: Yes, knitted polyester wipes are currently the best overall choice. They perform well in terms of absorbency, durability, and controlling particle release. Wipes used in sterile environments must also undergo sterilization—typically through gamma irradiation—to ensure bacterial contamination is reduced to no more than one in a million wipes, known as the sterility assurance level (SAL) of 10⁻⁶.

New Lab Member: Why is gamma irradiation preferred for sterilization?

Product Manager: Gamma irradiation is favored because it's fast, efficient, cost-effective, and leaves no residue. It's also better at reducing the endotoxin levels in wipes compared to electron beam irradiation. While other methods like dry heat, steam, and chemical sterilization are also used, we need to ensure that these processes don't negatively affect key wipe properties such as absorbency or particle release.

New Lab Member: How do we ensure that wipes meet sterility requirements?

Product Manager: There are rigorous sterilization protocols in the industry. We use microbiological testing to determine the bioburden of wipes and adjust sterilization conditions based on that data. After sterilization, we also verify that the wipe packaging remains sealed to prevent contamination. Each shipment of sterile wipes should come with a compliance certificate detailing the sterilization date, batch number, and conditions.

New Lab Member: This sounds very thorough! Thanks for explaining everything—I feel much clearer on how to choose cleanroom wipes now.

Product Manager: You're welcome. Remember, in sterile environments, every detail matters. Any oversight could lead to contamination.

Product Recommmedation: WP4302 Polyester Cleanroom Wipes

WP4302 is made from 100% polyester fibers and is a wipe designed to be cleaned in a cleanroom environment. Developed specifically for the pharmaceutical industry and other critical sectors, its low particle structure provides high absorbency and extraction levels, making it ideal for cleaning surfaces, equipment, and parts.

Product Features

• Made from polyester material, with high absorbency, perfect for spill control;

• Ultrasonically sealed edges, minimizing lint release;

• Extremely high cleanliness, with low levels of ions and non-volatile residues;

• Excellent chemical compatibility, compatible with a wide range of cleaning and disinfecting solvents;

• Safe for autoclave sterilization;

• Individually batch-coded for easy tracking and quality control.

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