Cleanroom Services

After a cleanroom has been certified, the cleanroom is often than qualified to demonstrate and document that the environmental conditions in the classified cleanrooms are suitable for manufacturing or compounding.  As part of the qualification program, the sampling plan shall be risk based as required by ISO 11644 and ISO 14698.  As such, organizations are required to document a risk assessment in order to develop a monitoring plan.

The FDA requires that manufacturers of pharmaceuticals, including compounding pharmacies, qualify and validate the disinfection procedures used in manufacturing and cleanroom environments in order to demonstrate the procedures are effective in inactivation or removal of microorganisms.  Disinfectant efficacy testing protocols are designed and performed per guidance available in ASTM E 2315, USP <1072>, and ASTM E 26140.

Clean Room Validation

Clean Room Qualifications including automated controls systems (SCADA, BMS)

Testing includes:

  • Temperature and relative humidity mapping and monitoring
  • Environmental monitoring master plan
  • Viable and non-viable particulate testing
Disinfectant Efficacy

Bacterial and Fungal Disinfectant Efficacy Studies

 LexaMed assists pharmaceutical and medical device manufacturers by conducting in-vitro and in-situ disinfectant efficacy studies. Manufacturers must validate disinfectant regimens used in cleanrooms and other controlled areas to demonstrate efficacy of the disinfectants.   Disinfectant efficacy testing is conducted per several standards including AOAC Chapter 6 tests, ASTM E 2315, USP General Chapter 1072 and ASTM E 26140.  Typical studies use coupons constructed of surface materials found in the facility. Coupons are inoculated with ATTC traceable organisms as well as environmental isolates unique to the client’s manufacturing facility.  Application of the disinfectants to the coupons reflects the actual disinfectant application method used at the client facility.  The effectiveness of disinfecting solutions against organisms within a manufacturing facility is becoming an increasing area of concern to both manufacturers and regulatory agencies. Below is a brief description of a disinfectant efficacy study.

In-vitro Study (in Suspension):

  • Ready-to-Use solutions of each antimicrobial product are challenged with each organism in duplicate or triplicate test tubes. After a determined dwell period survivors are extracted and recovered for determination of a log10 reduction value.
  • The extraction method is validated for its neutralization efficacy against all solutions and organisms.

In-situ Study (with Surfaces):

  • Surface coupons are cleaned and sterilized to eliminate any possible background contamination.
  • The extraction method for each organism from each surface type is qualified demonstrating an acceptable efficiency.
  • The recovery and incubation method is validated for its neutralization efficacy using an un-inoculated coupon.  This is conducted for each organism and surface coupon combination.
  • Duplicate or triplicate coupons are inoculated with an organism challenge of not less than 105 CFU.  A coupon set is prepared, disinfected, and allowed to dwell for a period of time matching actual client use.
  • After the exposure period, each coupon is extracted for the surviving population using the qualified method.
  • Disinfectants are used near their expiration date if possible.

Example of a Test Matrix:

Antimicrobial Agent Materials
(tested with all agents)
Microorganisms Time Challenges
Decon-Ahol (70% IPA)Hypo-Chlor (chlorine)


Decon-Spore (peracetic acid)

Steri-Perox (hydrogen peroxide)

Stainless Steel (316)Lexan (clear plexiglass)

Wall (epoxy coated)

Delrin (hard plastic)

Nitrile (gloves)

Pseudomonas aeruginosaStaphylococcus aureus

Candida albicans

Aspergillus brasiliensis

Bacillus subtilis

Environmental Isolate #1, Bacillus sp.

Environmental Isolate # 2, Staphylococcus epidermidis

5 / 10 / 15 minutes for all organisms, surfaces, and solutions
Environmental Monitoring

Environmental Monitoring

 LexaMed offers an environmental monitoring program that integrates many of our core competencies into a comprehensive program to address and support the requirements of our client base. The program can be applied to medical facilities operating in an ISO 8 manufacturing area to aseptic pharmaceuticals manufacturing conducted in ISO 5 environments.The program can be adopted in total or individual elements can be applied to your specific application. The program includes the following elements:
  • Environmental Monitoring Master Plan.   An experienced LexaMed consultant can work with you to design a program for your needs per ISO 14698-1:2003, including monitoring frequency, monitoring site selection, clean/disinfection results and location, etc. Alternatively, the LexaMed consultant can audit your existing program against current regulatory requirements and expectations as well as best industry practices.
  • Contract Monitoring.   A trained LexaMed associate will conduct viable and/or non-viable monitoring at your site. We can provide the equipment for you to sample at your site. We can incubate, enumerate, and compile data on samples.

  • Organism Identification.   LexaMed can determine the colony morphology, perform gram stain, identify to species level, provide digital photographs of colony and cellular morphology, create a customized “Microbial Isolate Atlas”, and provide data analysis, evaluation and tending.
  • Create & Provide High Concentration Stocks of Predominant Isolates.   We can create customized stock suspensions for use in Disinfectant Efficacy studies, cleaning studies and validation studies. We can maintain your culture isolates in-house for future use. A shelf life can be established for your customized suspension via a stability program.
  • Create & Provide Low Concentration Stocks of Predominant Isolates.   We can create customized stock suspensions for use in Growth Promotion and Recovery studies. A shelf life can be established for your customized suspension via a stability program.
  • Microbial Isolate Resistance Evaluation.   This includes disinfectant resistance and sterilant resistance (D-value) – Steam, Ethylene Oxide, Disinfectant, Dry Heat, UV, and others. We can create custom Biological Indicators (BIs) from spore isolates.