At Allegiance Industries, we always customize our process to your specific site needs and standards. Our teams utilize GMP Cleaning practices in cleanroom spaces for your facilities. Here’s what that includes:
Operating the Cleanroom:
Our GMP trained teams understand that maintaining a cleanroom is imperative to our client’s manufacturing production. We maintain these GMP standards through:
- Minimizing the amount of potential pollutants entering and exiting production
- Only allowing trained personnel to access cleanrooms
- Regular cleaning of cleanroom space
- Regular maintenance of equipment
- Regular checking of air filters and airflow
- Re-validating the cleanroom space
Gowning:
Allegiance Industries is able to provide cleanroom gowning specific to your site classifications and applications. Through following your site’s sterile garb and processing requirements, we are able to ensure that your cleanroom remains free of contamination. Whether your facility is ISO 8 or ISO 5, we have the experience to make sure all employees are in compliance.
Good Documentation Practice (GDP):
Allegiance Industries employees are able to create and maintain GDP through attention to detail and GDP sign offs. By using GDP, we are able to provide consistent quality assurance to our clients. Our GMP cleaning practices follow GDP requirements implemented per Code of Federal Regulations (CFR) and client Standard Operating Procedure (SOP) requirements.
FDA Audit’s:
Our trained teams sustain a goal of maintaining your facility with a “Tour Ready” appearance 24/7. We are constantly making sure that your facility is free of microbial contamination. We follow your specific site protocols and ensure the correct number of trained associates are present at all times. All associates are trained to enter and exit the GMP areas correctly using proper gowning & changing procedures. Our staff is trained to use the proper equipment and cleaning agents compliant with your cleanroom classifications.
How We Maintain a Safe and Controlled Cleanroom Environment:
Using Cleanroom-Compliant Supplies for Cleaning: When providing sanitation services for cleanrooms, it is imperative that all cleaning supplies are rated for cleanroom use in your specific ISO Class. Our teams specifically use Spore-Klenz and Coverage Plus products. This maintains a decontaminated environment that is safe for employees and manufactured materials. At Allegiance Industries, we understand the proper particle-to-surface bonding to provide optimal cleaning efficiency.
Maintaining the Right Temperature and Humidity: Most cleanrooms require a humidity level which typically falls between 30-40% RH with an air temperature of around 70°F. This type of environment ensures a lack of bacteria growth, corrosion, and static electricity while also allowing employee comfort, avoiding any negative particles that could be released into the environment.
Types of Cleaning used in Cleanrooms:
Wet Cleaning: Wet cleaning is used to remove contamination with the use of a cleaning fluid. This technique is typically used in cases when wiping is not enough to completely remove particles from a surface. We choose our “wet cleaning” solutions based on the surface material and whether disinfection or sterilization is the goal to ensure that the space is being cleaned adequately.
Dry Transfer: This type of cleaning is the polishing and/or wiping of a surface using an absorbent material. When “dry transfer” is used, it is essential to reduce the possibility of future contamination so we ensure all cloths and wipes used in janitorial procedures consist of durable materials that will not redeposit particles, shed, or easily break down. We make these decisions based on your cleanroom’s ISO Class.
