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.comGENERAL E-MAIL: info@microbioenv.com
QUOTES/INQUIRY: Kym Faylor - kfaylor@microbioenv.comServices 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 EquipmentPharmaceutical, 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 TestingGeneral 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 CapabilitiesMICROBIOLOGICAL 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.
