Company
Information
ADDRESS:
177 North Commerce Way, Bethlehem, PA 18017.
BILLING/REMITTANCE ADDRESS: 177 North Commerce Way, Bethlehem, PA 18017
PHONE: (610) 866-7272
FAX: (610) 866 7287
WEBSITE: www.microbioenv.com
GENERAL
E-MAIL: info@microbioenv.com
QUOTES/INQUIRY: Kym Faylor - kfaylor@microbioenv.com
Services
Provided
Environmental
Monitoring
Environmental
Monitoring Analysis and Data Trending
CGMP Training for EM Equipment Use and Sampling Procedures
Onsite Sampling of your Facility
Rental of Environmental Monitoring Sampling Equipment
Pharmaceutical,
Nutriceuticals & Cosmetics
USP
Microbial Limit Testing
USP Nutritional and Dietary Supplement Testing
USP Antimicrobial Effectiveness Testing
CTFA Microbial Limit Testing
CTFA Antimicrobial Effectiveness Testing
Pharmaceutical Process and Purified Water Testing
Product Release Testing
Validation/Preparatory Testing
General
Microbiological Testing
Method
Validation
Bacterial Identification – biochemical reaction
Mold Identification – based on colony morphology
Most Probable Number Testing
Minimum Inhibitory Concentration/Minimum Lethal Concentration Testing
Cleaning Validation Studies (microbial)
Pathogen Screening - Staphylococcus, coliform, Pseudomonas, Salmonella
etc.
Reporting
Results
A
client may ask for preliminary results during the course of a study.
It must be understood that only the final written report after being
reviewed and approved is considered to be valid. Final reports will
be issued in a timely manner.
All
results will be reported to the client. Decisions involving nonconformity
of samples are the client’s responsibility. MICROBIOLOGICAL
ENVIRONMENTS will perform retesting and adjunct testing at the
client’s request to assist in the decision.
Sub-contracting
of services
If
it is determined that a service is out of the scope of MICROBIOLOGICAL
ENVIRONMENTS capabilities the client will be notified prior to
performing testing for directives on sub-contracting of services.
Change
Notification
If
MICROBIOLOGICAL
ENVIRONMENTS
makes a system change which affects a client’s results or procedure
the client will be notified of the change according to MICROBIOLOGICAL
ENVIRONMENTS standard operating procedure(s). It is the client’s
responsibility to determine the impact of the change on the accuracy
of the results and the suitability of testing.
Terms
and Conditions
Samples
Submitted for Analysis
Samples submitted for analysis must be accompanied
by a chain of custody form.
All samples must be clearly labeled, labels should include name of sample,
lot number, date sample was taken, and sample type.
Unless otherwise directed all testing will be performed according to MICROBIOLOGICAL
ENVIRONMENTS protocol and SOP's. Testing may be done according to client directives or specifications.
Sample
Pick-Up Service:
A
courier fee of $30.00 is applied to sample pick-up within a 20 mile
radius from the laboratory, scheduled before 1:00pm on a regular business
day. Any distance greater than 20 miles will be based upon travel time
and billed at $75.00/hour.
Non-Routine Analysis:
MICROBIOLOGICAL
ENVIRONMENTS
can conduct special studies. Please call for pricing.
Turnaround Time:
Our goal is to meet your needs. Most analysis will begin on the day
of receipt if received before 1:00pm eastern standard time with a possible lead time of five business days. Final reports
are generally mailed to the client within 10 business days after all
testing has been completed.
Pricing:
Published
prices herein apply to most test samples. Samples which require special
handling, extra processing or manipulations may incur additional charges.
MICROBIOLOGICAL
ENVIRONMENTS
will provide price quotations after evaluation of the samples or protocol,
prior to initiation of the work.
A minimum laboratory reporting fee of $40.00 will apply. Prices include submission of a final report by US Mail. Requests for overnight delivery,
additional copies of reports and sample returns will incur additional
charges. Any requested written response or interpretation of results will be invoiced at an hourly rate plus a $50.00 adjunct reporting fee.
Volume discounts may apply. Prices are subject to change without
notice; however quoted prices will be honored for 60 days.
MICROBIOLOGICAL
ENVIRONMENTS
accepts checks drawn on US Banks, and wire transfers.
STAT Charges:
Clients
frequently need samples processed and/or reporting completed STAT. These
requirements will be honored when capabilities permit. An additional
fee of $50.00 will be applied for tests and/or reports generated STAT. Any samples
processed on weekends, holidays and/or after hours will also accrue additional
fees.
Terms:
Terms
are net 30 days. Fees are subject to change without notice. Negotiated
volume discounts are only applied to invoices paid within 30 days. Interest
at the rate of 2% per month will be added to accounts past 30 days.
A charge of $30.00 will be applied for each returned check.
Facility Description and Capabilities
Facility
Description
Our
1,500 square-foot facility was constructed from the ground up as a microbiology
laboratory. The location of equipment in the laboratory was designed
to allow for an efficient work flow pattern. The laboratory has a storage
area located in the warehouse, as well as multiple locked storage areas
inside the laboratory.
Facility Capabilities
MICROBIOLOGICAL
ENVIRONMENTS
is a multi-service microbiology laboratory. We specialize in establishing
and performing environmental monitoring programs for controlled areas.
We are capable of performing general microbiological testing, including
Microbial Limit Testing, Antimicrobial Effectiveness Testing, medical
device bioburden studies, bacterial and mold identifications, MIC/MLC
determination, pharmaceutical water testing. We perform testing according
to official compendia such as USP, BP, EU, CTFA, ASTM, AOAC, AAMI, and
USPHA.
Policies
Company
Philosophy
Our
goal is complete customer satisfaction under CGMP-compliance. This means
we must provide our clients with their three primary needs: accurate,
valid data, competitive turnaround times and excellent customer service.
Every aspect of the organization is maintained with these three objectives
in mind. We recognize that it is the commitment and professionalism
of our analysts that ensures accurate results; we therefore strive to
provide our employees with the training, facilities and supervision
necessary to perform quality work. We develop strong, long-term professional
relationships with our clients in order to understand their goals and
needs. A commitment to excellence is seen at every level of our organization.
Mission
Statement
It
will be the ongoing mission of MICROBIOLOGICAL
ENVIRONMENTS to provide the Pharmaceutical, Medical Device, Cosmetic
and allied industries with services that emphasize a pro-active approach
to microbiological quality assurance and quality control. We will endeavor
to develop a working relationship with each client that will include
a unique dedication to problem-solving. We will develop and install
programs to prevent episodes of microbiological contamination and will
help to shoulder our client’s microbiological quality assurance
concerns. We will remain above-all, open to communication and have put
into place policies and frameworks for establishing lines of communication
and responsibility between ourselves and our clients; we see these as
critical in the business of quality assurance and quality control. We
will be flexible to our clients’ needs but will remain stalwart
in adherence to internal and compendial guidelines; so-doing, we will
serve as a valuable extension of their quality control/ quality assurance
programs.
Vision
Statement
MICROBIOLOGICAL
ENVIRONMENTS’
vision is to be recognized by our clients as a vital and cooperative
adjunct service to their quality assurance program. We will strive to
conduct business in a friendly atmosphere and with management and employees
committed to excellence, we will experience continued improvement and
growth of our testing services. We will always maintain high business
and ethical standards for the benefit of our customers and employees.
Confidentiality
The
laboratory maintains the confidentiality and proprietary rights of all
information, including the type of work performed and the results of
tests to the extent allowable by state law and in accordance with company
administrative procedures.