Cleanroom Cleaning Services
Is your cleanroom clean enough? Does it meet the standards of the FDA or CFR? Imperial’s experienced crew is trained to follow procedures and help you meet standards.
Maintaining a cleanroom that is up to standard is essential for industries such as pharmaceuticals and manufacturing.
Imperial’s specialized cleanroom cleaning services comply with strict industry standards, including ISO 13485:2016 and FDA 21 CFR 820.70, ensuring the highest level of cleanliness and contamination control.
Imperial’s operations team trains the janitorial personnel to use approved chemicals and specialized equipment like HEPA-filtered vacuums. During training, the janitorial staff learns to comply with the company’s established procedures, like record keeping and gowning requirements.
Our comprehensive cleaning procedures include daily, weekly, monthly, and quarterly tasks tailored to the specific needs of each cleanroom classification. We address all critical areas, including machine rooms, gowning areas, and transfer rooms, employing a top-down approach to minimize contamination.
Contact us to learn more about our cleanroom cleaning services. We can offer you a brief introductory call. We will tell you how we can help you meet your standards.
More on cleanroom cleaning.
Cleanroom Specifications: In the cleanroom cleaning procedure, only personnel that have been trained thoroughly in all aspects of the specific cleanroom should be authorized to work. For example, since minimizing contaminants is as important as cleaning, gowning techniques, how to properly use approved cleanroom cleaning supplies and other client procedures must be followed to clean a cleanroom effectively.
Requirements example:
APPLICABLE STANDARD
ISO and FDA standard
APPROVED MATERIALS
· Quaternary Disinfectant Arena: - 1 oz. per 1-gallon of water. Allow solution to remain wet for 10-minutes with no contact or movement over the area. Use on weeks starting with an even number.
· Quaternary Disinfectant Cleaner Concentrate- 3 oz. per 1-gallon of water. Allow solution to remain wet for 5-minutes with no contact or movement over the area. Use on weeks starting with an odd number.
· Sterilize 70% Isopropyl Alcohol – surface disinfectant for critical surfaces and routine glove decontamination
· 70% Filtered Isopropyl Alcohol –non-sterile surface disinfectant for non-critical surfaces.
· Mop Head/Sponges and Mop Covers–TruCLEAN Mop Heads/Sponges and Mop Covers or equivalent.
· Lint-Free wipes
EQUIPMENT/SUPPLIES
Dedicated equipment:
o All dedicated cleaning equipment and supplies will be stored in an area only accessible from the cleanroom and/or anteroom. Dedicated equipment and supplies will only be used in the dedicated areas.
o Any equipment that enters the gowning room, must be wiped-down with 70% Isopropyl Alcohol and a clean lint-free wipe before crossing the bench onto the ‘clean’ side of the gowning room.
o Only lint-free wipes are allowed in the cleanroom. Paper towels or lint—generating wipes are not allowed.
Dedicated Mop Bucket System - Drain, rinse, and wipe dry after use. Do not store any supplies in the buckets when not in use.
Mop Head/Sponge, Cloth Covers and Handle System - TruCLEAN Mop Heads/Sponges and Mop Covers or equivalent.
Safety Goggles/Glasses
Disposable Frock/Smock - Select a new frock each day. Dispose of frock at end of shift.
Hair Cover - Single use only. Do not reuse.
Beard Cover - Single use only. Do not reuse.
Shoe Cover - Do not wear on the ‘dirty’ side of the gowning room. Single-use only. Do not reuse.
Latex-Free Gloves - Single use only. Do not reuse. Sanitize gloves with hand sanitizer or sterile 70% Isopropyl Alcohol.
Lint-Free Wipes - Single use only. Do not launder. Do not reuse.
HEPA Filtered Vacuum - Wipe down with 70% Isopropyl Alcohol and a lint-free wipe, before and after use. Pay close attention to nozzles, hoses, and wheel assembly.
Tacky Mats - Replace daily at the end of all cleaning duties.
Dedicated Step Stool/Ladder - Wipe with Isopropyl Alcohol, using a top to bottom order, before and after use.
PREPARATION PRE-CHECK
Verify that approved cleaning/sanitizationagents are available and within their expiration dates.
Safety goggles and gloves are to be worn at all times during cleaning, sanitization and pre-mixing of the disinfectants.
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Learn more about clean room procedures ...
Get a copy of the “Comprehensive Cleanroom Sanitization Guideline”, fill out the form bellow.
Do you want to know more about cleanroom cleaning procedures?
Get a copy of the “Comprehensive Cleanroom Sanitization Guideline.” A real-life example from a medical device manufacturer.
