Adapting to Fit your Needs...

will adapt its programs to fit your needs:

Concept and Design of Environmental Monitoring Programs

Our sampling and testing programs are flexible and can be designed to meet small-scale needs as well as the critical requirements of larger scale pharmaceutical and medical device operations.

We will evaluate your facility for likely microbial sources, harbors and potential contamination and control problems, then develop sampling plans with a rationale for site selection and quantity of samples taken.

We can design and provide color-coded sampling plan maps for quick and easy reference to site and sample types.

Conducting Environmental Sampling On-site

Our precision in sampling technique and attention to sample plan detail reflect over 35 years experience in conducting critical sampling programs.

Our trained sampling staff can be scheduled for routine on-site sampling sessions; and we will be "on call" for emergency or post-remediation re-sampling sessions.

Testing is performed using state of the art sampling equipment and microbiological media manufactured and controlled by world renowned suppliers.

Our equipment is calibrated with NIST traceable standards.

CGMP Training of your Staff to Sample your Facility and Directives for Submission to our Facility

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:

Sampling formats and evaluation techniques can be customized; we can simply determine gross 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 colonies. 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 bio-Merieux (API) and BBL Crystal systems are normally used in conjunction with conventional laboratory methods. Isolates can be outsourced for identification by fatty acid profile 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. We can determine the levels and types of microbial contaminants present in your facility as well as 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 also 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 Sample Submission Form Contact Us	MICROBIOLOGICAL ENVIRONMENTS will adapt its programs to fit your needs: Concept and Design of Environmental Monitoring Programs Our sampling and testing programs are flexible and can be designed to meet small-scale needs as well as the critical requirements of larger scale pharmaceutical and medical device operations. We will evaluate your facility for likely microbial sources, harbors and potential contamination and control problems, then develop sampling plans with a rationale for site selection and quantity of samples taken. We can design and provide color-coded sampling plan maps for quick and easy reference to site and sample types. Conducting Environmental Sampling On-site Our precision in sampling technique and attention to sample plan detail reflect over 35 years experience in conducting critical sampling programs. Our trained sampling staff can be scheduled for routine on-site sampling sessions; and we will be "on call" for emergency or post-remediation re-sampling sessions. Testing is performed using state of the art sampling equipment and microbiological media manufactured and controlled by world renowned suppliers. Our equipment is calibrated with NIST traceable standards. CGMP Training of your Staff to Sample your Facility and Directives for Submission to our Facility Proper cleanroom behavior Proficiency in aseptic handing and sampling Proper use and maintenance of equipment Proper sampling technique Awareness of sources and harbors Proper gowning technique Handling and shipment of samples Training in-house personnel in sampling and submission of samples to MICROBIOLOGICAL ENVIRONMENTS for evaluation and reporting. Compliance with regulatory and compendial standards and guidelines. Awareness of potential contamination sources, which may prevent an exceeded concern level. Provide Calibrated Sampling Equipment and Media 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 Environmental Samples and Reporting Sampling formats and evaluation techniques can be customized; we can simply determine gross 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 colonies. 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 bio-Merieux (API) and BBL Crystal systems are normally used in conjunction with conventional laboratory methods. Isolates can be outsourced for identification by fatty acid profile 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. We can determine the levels and types of microbial contaminants present in your facility as well as 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 also 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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