Adapting to Fit your Needs...

...will adapt its programs to fit your needs:

For our clients who are conducting or plan to conduct an in-house environmental moniitoring program MICROBIOLOGICAL ENVIRONMENTS can provide you with calibrated sampling equipment, traceable to NIST standards. All media is provided with a manufacturer's certificate of analysis. In addition, we perform a quality control check of the media before it is sent to the client and after it is returned to our laboratory to verify that shipping and handling conditions did not affect media integrity. Equipment can be sent to you via overnight delivery for your trained personnel to sample your environment:

Analysis of your USP <1116> & <797>

Environmental Samples and Reporting

Sample analysis and colony identification techniques can be customized; we can simply determine total microbial content or expand the analysis, determining types and relative numbers of the various microorganisms routinely isolated.

For most non-critical manufacturing environments, where there may be higher counts of a wider variety of isolates, an organism type profile can be developed by characterizing colony types and Gram's stain morphology. This allows the tracing of likely contaminant sources when population increases occur.

For critical environments or for obtaining more detailed information about a population profile, a representative of each colony type may be Gram stained and identified to Genus/ species by any of various identification methods; the MIDI Sherlock fatty acid analysis, bio-Merieux (API) and BBL Crystal systems are normally used in conjunction with conventional laboratory methods. Isolates can be outsourced for identification by DNA sequencing or other automated analysis.

Evaluation and Trending of Data to Set and Monitor Alert and Action Levels

Client data is maintained in database format and trends in numbers and types of microorganisms can be evaluated. Alert! and remedial Action! levels are established based on these trends; each set of site specific data is compared with its historical trends. If a site is determined to be out of control, an Alert! or Action! prompt appears for that site on the report sheet. This helps to initiate investigation of the condition, insuring compliance with CGMP's.

We employ a flexible database system and concise, easily understood reporting formats; and when questions arise, you will always find a friendly, cooperative and helpful associate.

We can assist you in drafting of pertinent in-house SOP's for responding to, following-up and documenting Exceeded Concern Level episodes. This assures compliance with the most critical regulatory aspect for any environmental monitoring program. Without properly designed and carried out response SOP's, an otherwise good program could be meaningless.

We can provide on-site contamination control investigations to determine the levels and types of microbial contaminants present in your facility as well as contaminant sources and harbors. We can advise steps for remediation and will apply a follow-up monitoring program to check that microbial populations have been reduced and remain at the desired low levels.

We provide consultation on sourcing and remediation of bacterial endotoxin and particulate contamination of systems, facilities, raw materials and finished products.

We can conduct CGMP training of your personnel in microbiological awareness and recognizing potential contamination sources and harbors. We also provide remedial training in proper cleanroom habit/ behavior and gowning techniques.

We can provide protocols for antimicrobial cleaning validations and will interface with associate analytical laboratories for chemical cleaning validations.

Sterile media fills are an important diagnostic tool for evaluating aseptic fill, blow-fill-seal and other critical filling operations. We will interact with your Quality Assurance and Manufacturing groups in designing and conducting a CGMP-compliant media fill validation. We have the capacity to incubate and provide daily read-out of filled media containers in the SVP- class. We can provide the bulk media preparation/ sterilization, quality control and post-fill re-certification of the media as required.

We have extensive experience in drafting compendial-based standard operating procedures for support of quality assurance programs as well as laboratory testing and special projects. Our formats provide thorough yet concise outlines for conducting test methods and can include the associated raw data forms for CGMP compliance.


Home History Environmental Monitoring <797> Compliance <797> Training General Microbiological Testing About Us Special Information Downloadable Forms Registrations & Licenses Contact Us Terms of Use	Environmental Monitoring MICROBIOLOGICAL ENVIRONMENTS... ...will adapt its programs to fit your needs: Provide Calibrated Sampling Equipment and Media For our clients who are conducting or plan to conduct an in-house environmental moniitoring program MICROBIOLOGICAL ENVIRONMENTS can provide you with calibrated sampling equipment, traceable to NIST standards. All media is provided with a manufacturer's certificate of analysis. In addition, we perform a quality control check of the media before it is sent to the client and after it is returned to our laboratory to verify that shipping and handling conditions did not affect media integrity. Equipment can be sent to you via overnight delivery for your trained personnel to sample your environment: RCS Air Sampler RCS Plus Air Sampler SAS Air Sampler Contact Plates RCS Air Strips TSA Plates Swabs Analysis of your USP <1116> & <797> Environmental Samples and Reporting Sample analysis and colony identification techniques can be customized; we can simply determine total microbial content or expand the analysis, determining types and relative numbers of the various microorganisms routinely isolated. For most non-critical manufacturing environments, where there may be higher counts of a wider variety of isolates, an organism type profile can be developed by characterizing colony types and Gram's stain morphology. This allows the tracing of likely contaminant sources when population increases occur. For critical environments or for obtaining more detailed information about a population profile, a representative of each colony type may be Gram stained and identified to Genus/ species by any of various identification methods; the MIDI Sherlock fatty acid analysis, bio-Merieux (API) and BBL Crystal systems are normally used in conjunction with conventional laboratory methods. Isolates can be outsourced for identification by DNA sequencing or other automated analysis. Evaluation and Trending of Data to Set and Monitor Alert and Action Levels Client data is maintained in database format and trends in numbers and types of microorganisms can be evaluated. Alert! and remedial Action! levels are established based on these trends; each set of site specific data is compared with its historical trends. If a site is determined to be out of control, an Alert! or Action! prompt appears for that site on the report sheet. This helps to initiate investigation of the condition, insuring compliance with CGMP's. We employ a flexible database system and concise, easily understood reporting formats; and when questions arise, you will always find a friendly, cooperative and helpful associate. Drafting Support SOP's for Response/ Documentation/ Follow-up to ECL's We can assist you in drafting of pertinent in-house SOP's for responding to, following-up and documenting Exceeded Concern Level episodes. This assures compliance with the most critical regulatory aspect for any environmental monitoring program. Without properly designed and carried out response SOP's, an otherwise good program could be meaningless. Consulting on Contamination Vectors, Contamination Control and Remediation We can provide on-site contamination control investigations to determine the levels and types of microbial contaminants present in your facility as well as contaminant sources and harbors. We can advise steps for remediation and will apply a follow-up monitoring program to check that microbial populations have been reduced and remain at the desired low levels. We provide consultation on sourcing and remediation of bacterial endotoxin and particulate contamination of systems, facilities, raw materials and finished products. We can conduct CGMP training of your personnel in microbiological awareness and recognizing potential contamination sources and harbors. We also provide remedial training in proper cleanroom habit/ behavior and gowning techniques. Special Projects such as Cleaning Validations & Media Fills We can provide protocols for antimicrobial cleaning validations and will interface with associate analytical laboratories for chemical cleaning validations. Sterile media fills are an important diagnostic tool for evaluating aseptic fill, blow-fill-seal and other critical filling operations. We will interact with your Quality Assurance and Manufacturing groups in designing and conducting a CGMP-compliant media fill validation. We have the capacity to incubate and provide daily read-out of filled media containers in the SVP- class. We can provide the bulk media preparation/ sterilization, quality control and post-fill re-certification of the media as required. Drafting Standard Operating Procedures and Protocols. We have extensive experience in drafting compendial-based standard operating procedures for support of quality assurance programs as well as laboratory testing and special projects. Our formats provide thorough yet concise outlines for conducting test methods and can include the associated raw data forms for CGMP compliance. .
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