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:
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.
.