Providing Cleanroom Certification, ASHRAE 110 Testing, Calibration, Decontamination, USP 797 Solutions, Compressed Air Line Testing, Environmental Monitoring and Qualification Services

Contamination Consultation

Surface Decontaminations

Room Decontaminations

Mold Remediation

Biological Safety Cabinet Decontaminations

Biological Safety Cabinet Formaldehyde Decontamination Procedures

Techniques on
Biological Safety
Cabinet Decontaminations Powerpoint Presentation

Incubator Decontaminations

Other Equipment Decontaminations

Decontamination Projects

Decontamination Services

Micro-Clean, Inc. offers cleanroom decontamination, critical environment decontamination and equipment decontamination.

Our decontamination services include:

• Contamination Consultation for biologically sensitive or controlled environment areas;
• Surface Decontamination of equipment, laboratories, and duct work from biologically and chemically active residuals;
• Room Decontaminations from all viables, including bacterial spores;
• Mold Remediation within biologically sensitive areas;
• Biological Safety Cabinet Decontaminations utilizing formaldehyde or chlorine dioxide;
• Incubator Decontaminations using Micro-Clean's four-type process;
• Other Equipment Decontamination utilizing formaldehyde, chlorine dioxide or one of multiple liquid disinfectants and sterilants.
  

  Overview

  Since 1983, we have developed the current protocols used for decontamination services by Micro-Clean. We have managed more than 100 large-scale decontamination projects.

SOP’s are written to conform to best practices, available through NSF International, the EPA and our own decontamination specific procedures. A listing of our decontamination SOP’s is available to customers upon request.

Prior to performing a room or specialty space decontamination Micro-Clean’s customer specific “Decontamination Setup Document” is utilized. This is a combined instruction set and survey, with over 60 questions, covering all aspects of the process, from start to finish, so you know exactly what, when, where, and how all functions will be performed. This document serves as the guide followed during the decontamination process.

Survey items within the “Decontamination Setup Document” include:

• Initial Support Documents
• Space or Room Set-up and Sealing Issues
• HVAC Issues
• Site Utility Issues
• Internal Decon Space Equipment or Items Issues
• Decontamination Time Sequence
• Safety Issues
• Permit, Training, Access, and SOP Issues
• Acceptance / Validation Issues

Typical reports following room decontamination services specifies room and/or HVAC identification, chemical quantity data, room and HVAC sealing locations, power usage, recirculation of RH and gases, chemical generation locations, room and HVAC pressurization's, biological indicator locations and results, operating temperature and humidity, residual gas concentrations, time sequences and surface and drain decontamination procedures, when appropriate.

Prior customers have included for Merck, Centocor, Wyeth, Ortho Diagnostics, Aventis Pasteur, GSK, Mova, DuPont, University of Pennsylvania, Geisinger, Osiris Therapeutics, Norvartis, Johnson & Johnson and Bristol-Myers Squibb, as well as for construction contractors including Skanska, Bovis Lend Lease, and IPS.

Decontamination Services Defined:

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Surface Decontaminations Teams of qualified technicians, trained in use of Personal Protective Equipment, enabling quick and safe project completion. Use of multiple liquid disinfectants / sterilants Sodium Hypochlorite (ph neutralized or basic) Peracetic Acid / Hydrogen peroxide Chlorine Dioxide detergents and alcohols Hand application and/or fogging

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Room Decontamination of Viables Start-to-finish process (excluding biological validation) in less than 24 hours with chlorine dioxide or formaldehyde (true gases). Over 20 years with more than 100 safely executed space decons. MCI's validated In-Line Decon Cart, allowing simultaneous thorough decontamination of exhaust HEPA’s and room ductwork. Simultaneous decontamination of biological safety cabinets, incubators and other devices within space. Routine Biological validation performed with 1e6 B.atrophaeus (ATCC#9372, formerly B.subtilus) or G. stearothermophilus (ATCC#7953). Validation by log reduction method, not via "Go/NoGo". "Mock" decons with entire process (start to finish), verifying appropriate lab sealing.

MCI’s In-Line Decon Cart

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Incubator Decontaminations Customized decontaminations specific to the incubator model Micro-Clean’s “Incubator 4-Type-Decon” is used for the process Model specific part kits may be required Each incubator decontamination is validated to ensure an adequate bioload reduction

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Other Equipment Decontaminations Casework, cabinets, HLF’s or VLF’s, Containment Devices, CFH’s, Centrifuges, Refrigerators, Freezers, Washers, water baths, shakers, Bio-reactors, tanks, CIP’s, computers, or any other lab or production equipment Micro-Clean aids in the selection of the most appropriate type of decontamination for the specific equipment set.

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Typical Projects (within past 2 years):

• BL3 Suite and duct work PF decon in PA pharma facility – 8700 ft³
• BL3 suite mock decons in PA pharma facility – 22,000 ft³
• BL3 Suite and duct work PF decon in MD biotech facility – 8200 ft³
• BL2 suite mock and real decons in NJ pharma facility – 6800 ft³
• Four-story vivarium center surface sanitization in NJ pharma facility – 358,000 ft²
• Chlorine dioxide decontamination of large animal hospital ICU in PA–170,000 ft³

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