Cleaning Validation Swab Kits

Description

The Cleanroom Validation Swab Kit is specifically designed for surface sampling during cleaning validation processes. This kit helps ensure that equipment, utensils, and surfaces are free from residue, such as active pharmaceutical ingredients (API), cleaning agents, and microbial contaminants. By providing an efficient and accurate method for sampling, this kit is essential for verifying that cleaning procedures meet regulatory requirements and preventing cross-contamination between different product batches or drug types, ensuring the safety and purity of pharmaceutical products.

Product Features:

1. Accurate Residue Detection:

   • The swabs are used to wipe surfaces of equipment and utensils, collecting possible residues like API, cleaning agents, and other contaminants. The collected samples are then analyzed to identify and quantify the types of residues, confirming that the cleaning process meets required standards.

2. Prevention of Cross-Contamination:

   • By ensuring that residues do not remain on surfaces between batches or product types, the kit helps prevent cross-contamination, protecting the integrity and safety of pharmaceutical products.

3. High-Performance Swabs:

   • The swabs are made of polyester fibers with low Total Organic Carbon (TOC) content, ensuring minimal interference with testing results. They have excellent solvent compatibility and high recovery rates, effectively adsorbing and releasing residue.

4. Specialized Sample Bottles:

   • The kit includes borosilicate glass sample bottles treated to ensure a low TOC background. The bottles feature an integrated cap and membrane design for easy sampling and analysis while reducing contamination risks during sample handling.

5. Comprehensive Kit with Accessories:

   • Some kits include additional tools such as markers for labeling sample areas and sample information, and tweezers for proper handling of the swabs, providing a complete solution for residue collection and analysis.

Scope:

The Cleanroom Validation Swab Kit is ideal for industries that require strict cleaning procedures, including pharmaceutical manufacturing, biotechnology labs, food production, and cosmetics. It is an essential tool for validating cleaning processes, ensuring compliance with regulatory standards, and preventing contamination between different product batches.

Parameters:

• Swab Material: Polyester fiber

• Swab Features: Low TOC content, high recovery rate, solvent compatibility

• Sample Bottle: Borosilicate glass, low TOC background

• Included Accessories: Swabs, sample bottles, markers, tweezers (depending on the kit)

• Applications: Pharmaceutical cleaning validation, food industry, cosmetics manufacturing

• Storage: Store in a cool, dry place