GMP, CLEANROOM & COMPUTER ROOM CLEANING


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ACM’s GMP Cleanroom Cleaning

ACM’s ISO 9001:2008 Certified GMP cleanroom cleaning reduces non-viable (dust, metals, fibers, salts, bases, smoke, etc.) and viable (bioburden) particles. ACM technicians use non-linting and microfiber materials with distinct properties matched to the surfaces in your facility.  The type of contamination, whether viable or non-viable is targeted. Microcleaning is a key factor in product compliance and yield improvements, both contributing to higher customer profitability.

See: ACM’s Microclean vs. Janitorial Cleaning

ACM’s cleanroom cleaning knowledge is at the expert level and we have over 20 online classes for our Cleaning Technicians. The training consists of Good Documentation Practices (GDP’s), cleaning methodology, cleanroom technology, safety, microbiology and aseptic techniques. Once classroom instruction is completed, the technician then studies the customer’s SOPs before starting site specific on-the-job training. 

ACM’s training methodology of starting from the cleanest end of the room, farthest from the exit, cleaning top down, ceilings, walls and lastly floors, has proven to decrease deviations by over 200 times or improved yields up to 99% at most large companies. 

Please see bottom of the page for details on ACM’s cleaning methodology for Computer Rooms.

 


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ACM Cortaclean GMP cleanroom Cleaning

Ancillary Benefits of ACM Services:

Our company develops a program tailored to your facility, product and process needs. Our cleaning programs deliver these additional cleanroom services:

SOP development and maintenance:

SOP (Standard Operating Procedures) may be developed for any of our services allowing for continued compliance to best industry practices.  SOPs are continuously maintained and edited for improvements and industry changes.

Personnel and cleaning workflow guidance:

Training, training and more training. Good habits are best maintained with regularly scheduled certified trainings according to our ISO 9001:2008 systems, customer SOPs and IEST cleanroom Recommended Practices for cleaning methodologies.

Periodic facilities and personnel inspection:

We are glad to do the inspection (lower case “i”) before the Inspection (capital “I”) takes place.  High marks are good for high-fives all around… and with high profits, management will be pleased.

Cleanroom policing:

Sometimes it’s better to have someone other than the rooster guarding the chicken house, so to speak.  ACM provides policing or monitoring on any schedule you wish.


Call ACM for Guaranteed Effortless Compliance

ACM brings you results whether by reducing cleaning related deviations, product process compliance or increasing yields. Costs of poor quality (COPQ) can account for a loss equal to 25-50% of a company’s overall revenue; deviations alone may cost over $20,000 each, without taking into consideration product delays and FDA violations.  Our certified technicians manage your cleaning program so your company can turn its focus to where it should be, on the production process. For more information on ACM’s GMP and cleanroom cleaning services, please see below, check out our FAQ section and Contact Us today and learn how ACM can deliver guaranteed effortless compliance to your facility.


GMP Cleanroom Cleaning

cGMP (Current Good Manufacturing Practices) contain both requirements and guidelines for manufacturing of food and drug products in a sanitary environment. The Food and Drug Administration FDA CFR Title 21 mandates that any building used to manufacture a drug, food, medical device, cosmetics or holding of such shall be maintained in a clean and sanitized condition.

Disinfection is the process of sanitization eliminating many or all bio-burden, including viruses, bacteria, molds and yeasts, except bacteria spores, on inanimate objects. Disinfection is achieved by liquid disinfectants.

A sporicide is required for effective elimination of spore-forming microorganisms. this process is usually performed during the initial validation cleaning methods and periodically thereafter, based on the validation outcome and documented SOPs.

Cleanroom Cleaning

Cleanroom cleaning methodology is the same as GMP cleaning above except a cleanroom detergent like Novaclean or DI water / Isopropyl blends like Protohol products are used instead of disinfectants. The cleaning process remains cleaning from the area in the room farthest from the exit, cleaning top-down, side to side to remove particulates. Cleanroom cleaning may also have added steps prior to the liquid cleaning phase such as vacuuming with HEPA filtered Nilfisk vacuums or using cloths to remove particles at 0.25 microns and larger. This step increases the effectiveness of the cleanroom cleaning.

GMP Sporicide Cleaning

A sporicide is required for effective elimination of spore-forming microorganisms. This process is usually performed during the initial validation cleaning methods and periodically thereafter, based on the validation outcome and documented SOPs.

GMP Cleaning SOP Documentation

ACM creates, documents and delivers GMP, SOPs (Good Manufacturing Practices, Standard Operating Procedures) based on customer requirements. ACM provides continuous improvement in the SOP documentation for both ACM SOPs and the customer’s SOPs. Facilities and ACM’s technicians are trained and certified on the SOPs and on GMPs for Documentation. For effortless compliance, our SOPs’ are written by area experts to comply with the most current international regulatory agencies’ requirements.

Supercleans

Supercleaners start at the ceiling or highest point and continue down the walls to the floor level. Superclean cleaning also starts from the area farthest from the exit door, and works out towards the least clean area, the entry/exit. The number and frequency of Supercleans vary depending on the requirements of the project.

Supercleans may include any or all of these cleanings: Top-down Cleaning, Air Handler Unit (AHU) Cleaning, Raised Floor Cleaning, Plenum Area Cleaning, High-Bay Cleaning, Computer Room and Data Center cleaning.

Clean-Build Cleaning and Construction Supercleans

Clean-Build is a process to start clean, build clean and stay clean. There are five levels of clean construction protocols. ACM is proud to have the best clean-build construction cleaning methods.

Protoclean cleaning starts at Protocol Level 1 to the completion of Certification at Level 5. Supercleans are performed before transitioning to each Protocol Level.

The cleaning may include any or all of the following:

  • Level 1 to Level 2 Rough Clean,
  • Level 2 to Level 3 Top-down before Blow-down,
  • Level 3 before Level 4 Top-down, Filter Grid Clean, Raised Floor Clean.
  • Level 4 to Level 5 Final Clean- all while continuously cleaning during construction on a daily basis.

If you need to construct a cleanroom, we will be glad to communicate the necessary protocols for cleaning and construction including Protocol training, temporary gowning and material entry rooms, monitoring the Clean-build process, cleanroom supplies and garmenting for each of the five levels.

ISO 14644-4 defines the Clean-build protocols and specifications for application when designing a cleanroom and construction methodology.

Post Construction GMP Validation Cleaning

Validation cleaning covers all aspects of the GMP cleaning procedures to validate predictable results as documented in the SOPs and used to set up alert and action limits. Further changes to the SOPs past successful validation require re-validation. Validation is usually confirmed by the statistical process of the environmental monitoring results. Validation cleaning may include changes in disinfectants, sporicides, cleaning materials and wipes.

Non-GMP Cleaning (Janitorial)

ACM ‘s sophisticated systems used for cleanroom cleaning and testing operations are simply converted to office and industrial janitorial services for our already satisfied cleanroom customers.

Some of the janitorial services we offer using “green” sustainability cleaning and products safe for the environment and people are:

  • Office cleaning
  • Kitchen sanitization
  • Blind cleaning
  • Carpet care
  • Construction clean up
  • Medical waste disposal
  • Emergency services
  • General maintenance
  • Hard surface floor care
  • Inventory control
  • Light industrial
  • Pressure washing
  • Restroom sanitation
  • Special event services
  • Supply management
  • Upholstery cleaning
  • Window cleaning

For more information on our Janitorial cleaning service visit our page HERE

Computer Rooms and Data Centers

The computer room needs to be cleaned to maintain the computer equipment integrity. ACM guarantees to remove dirt, dust, and other contaminants from your computer rooms leaving it 3 to 10 times cleaner

ACM’s certified technicians clean under the raised floors, the tops of floors, the room and equipment interiors and exteriors. Like in a cleanroom, cleaning is performed from the area farthest from the exit but cleaned from the bottom up. Wipes, mops and cleaning solutions are selected for equipment and surface compatibility. Any particles not removed by the Nilfisk HEPA filtered vacuums are removed by surface surfactants down to 0.5 microns.

The raised floor plenum requires routine cleaning. Even with the clean air supply from the plenum, gravity alone causes contaminates to settle under the floor. It doesn’t take long for the particles to accumulate, settle out, and be deposited in your equipment by the air supply under pressure designed to cool your equipment.

ACM’s cleaning processes are proven to remove particles and maintain a clean environment for your equipment and personnel.