Laboratory Services provides the highest quality and most cost effective microbiological testing services in the medical industry. Our professional staff develops and cultivates close working relationships with its clients allowing them to meet and exceed their demanding regulatory requirements and business goals. Our company offers a broad spectrum of services which include but is not limited to the following:

• Environmental Monitoring Programs

• Sterilization Cycle Development & Validation

• Clean Room Validations

• Product Validations

• Routine Testing Programs

• Regulatory Assistance

• Compliance Audits

• Custom Training Programs

Some of the routine testing conducted at Laboratory Services includes:

• Bioburden Testing

• Microbial work surface counts

• Sterility Testing

• Microbial air counts

• Product Inoculations

• Particulate counts

• Kinetic turbimetric LAL Testing

• Water Testing

• Kinetic turbimetric LAL Inhibition/Enhancement Testing

• Bacteriostasis/Fungistasis

• Growth Promotion

Our Quality Statement

Laboratory Services is committed to providing the highest quality microbiological testing services in conformance with applicable regulatory requirements while meeting and exeeding each customer’s service and business objectives.

• OPERATIONAL INFORMATION •

• Good Laboratory Practices (GLP)

All studies at Laboratory Services are performed according to basic “good practices”, including the use of written procedures, calibrated equipment and data storage, etc. Sponsors must designate studies to be performed according to the Good Laboratory Practices regulation.

• Confidentiality

All sponsor information and data is held for examination and discussion only between Laboratory Services and the sponsoring organization. Copies of standard confidentiality agreements will be provided upon request.

• Fees

Schedule of current fees is available on request. Special studies or testing which does not follow standard testing methodology will be priced separately.

• FAX Results

On request, test result summaries can be sent by fax, followed by mailed written report. Verbal reporting is not allowed. No fee will be added for fax services.

• Stat Services

To meet your needs, Laboratory Services provides pre-approved stat testing requests with no additional fees. Stat requests, must be coordinated with the Customer Service Representative.

• Purchase Orders

Purchase orders facilitate the administrative processing of test samples.

• Terms

Payment terms are met upon receipt of invoice.

PLEASE MAKE ALL CHECKS PAYABLE TO CURRIE MEDICAL SPECIALTIES, INC.

• Sample Submission

Identify each submission clearly including sample description, lot number, P.O. number, and specified test code from test schedule. Submit separate samples for each test if possible. Complete a test request form to accompany each group of test samples.

• Reports

Fees include one copy of final report to sponsor, and one copy of final report and supporting raw data to Laboratory Services archives. Extra copies are available on request with an additional fee.

• Special Fees

• Consultation $100.00/hour plus expenses

• Literature compilation $100.00/hour plus expenses

• Cancellation fee Varies

• Special Handling Varies

• Notification of Adverse Test Results

Clients are promptly notified of adverse test results by facsimile or telephone.

• FULL SERVICE ENVIRONMENTAL MONITORING PROGRAMS •

The experienced technical staff at Laboratory Services has the ability to evaluate microbial conditions associated with production operations and to develop strategic programs for environmental monitoring and control which meet both regulatory and business objectives.

Services include:

• Site specific program development

• Establishment and qualification of sampling locations

• Statistical evaluation of viable particulate recoveries from classified or non-classified
  production or controlled areas

• Comparison of viable particulate recoveries to established standards

• Viable and non-viable microbial particle sizing

• Development of routine environmental control procedures

• Low cost on site sampling and reporting programs

• Identification and tracking of predominant microorganisms

• Microbial evaluation of production or processing personnel

• Microbial evaluation of processing or sterile fill operations and equipment

• Complete procedural documentation and implementation

• Quantify microbial populations associated with dust or material surfaces

• Consultation

• Clean Room Certification

We welcome the opportunity to discuss your technical and consulting service needs.