Lewis Testing Services, Inc.   

 
 

 

Services Provided

Services

Contamination Control Testing & Certification

LTS assures that your contamination control equipment is providing the required personnel, environmental, and/or product protection. Our testing and certification program verifies and documents that your equipment is performing to appropriate national standards and manufacturer specifications.

LTS provides the highest quality testing and certification services backed by highly trained technicians and a comprehensive quality assurance program. Our technicians receive extensive in-house and manufacturer-provided technical training to assure that they are current in the latest industry developments. Technicians also receive on-going training on the latest occupational safety and health standards for their protection and yours.

LTS's quality assurance program rigorously adheres to equipment calibration requirements and documentation/review of certification testing results. In addition, we can provide field service technicians that are accredited under the NSF Biohazard Cabinet Field Certifier Program.

LTS has experience in testing and certifying:
LTS provides performance testing in accordance with recognized national standards and guidelines developed by:
  • ANSI/NSF International (Class II Biohazard Cabinets)
  • IEST (Unidirectional Clean Air Devices/ Cleanroom Testing)
  • ANSI/AIHA ASHRAE (Laboratory Ventilation and Fume Hoods)
  • SEFA (Laboratory Fume Hoods)
  • USP (All Aspects of Compounding Facilities)
  • ISO (Cleanroom Testing)
  • CDC-NIH (BSL-3 & 4 Laboratories)
  • Equipment Manufacturers

LTS is authorized to perform warranty repairs for all major equipment manufacturers, and has fast access to common parts, including HEPA filters, to minimize equipment down-time when repairs are required.

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Biosafety Cabinets

There are three main classes of Biological Safety Cabinets (BSCs).

When people refer to biological safety cabinets, they normally mean a Class II BSC. Class II BSC manufacturers recommend certification at least once a year. NSF International supports a consensus standard (Standard 49) addressing Class II BSC design, construction, and performance, which requires certification at least annually. Different types of users may need to meet industry or regulatory certification requirements. The Joint Council of Accredited Hospital Organizations (JCAHO) recommends certifications at least annually for BSCs used in health care organizations. USP 797 requires Compounding Pharmacy's BSCs to be certified semi-annually.

NSF International's Standard 49 recommends four containment tests for field certifications: downflow velocity profile test; inflow velocity test; airflow smoke patterns; and HEPA filter leak test. The four worker comfort and safety tests recommended by NSF International are: electrical test; lighting intensity test; vibration test; and noise level test. In addition, NSF now requires a site installation assessment test for ducted units. This test determines that the duct system is being operated under negative pressure, and that the alarm system is operating properly.

Class II BSCs are an important part of a biosafety program. With proper maintenance and service they can provide protection for many years. LTS Services, Inc. is uniquely qualified to execute a performance evaluation of your hood for certification, troubleshooting, repairs or general evaluation.

When LTS tests and certifies your contamination control equipment; such as a biosafety cabinet, you can be sure it will perform to appropriate national standards or manufacturer specifications. We have been testing, certifying, and maintaining contamination control equipment for many years.

We provide these services to a wide range of industries that use this equipment for research and production activities, including the pharmaceutical, health care, biomedical research, chemical, and biotechnology industries.

LTS performs service on an as-needed or service agreement basis. Service agreements are designed to meet your needs. For clients who have fixed budgets or just want peace of mind, our certification, labor or full maintenance service agreements provide a cost-effective solution to unanticipated maintenance requirements.

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Fume Hoods

Chemical fume hoods are used to contain and exhaust chemical vapors. They come in a variety of types and designs and are used for many different operations. When using a fume hood, it is important to have proper airflow, in order to avoid release of chemical vapors from the face of the hood into the worker's breathing zone. LTS offers face velocity measurement and smoke containment visualization as a means of documenting a fume hood's performance and for comparison to current standards (ANSI/AIHA, SEFA). This testing and certification procedure is a part of a lab's chemical safety management program. Other aspects, including preventative maintenance and inspections, chemical exposure monitoring, and periodic ASHRAE 110 testing can give a facility a complete program for fume hood management which LTS can also help in meeting these needs.

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Laminar Flow Units

The term Laminar Flow as it applies to hoods or clean air equipment can mean many things. "Laminar Flow" typically means air flowing in one direction (unidirectional) with very low turbulence. In a horizontal "Clean Bench" air flows straight out of the hood towards the operator. In a true Vertical Flow clean bench the air flows directly down onto the worksurface, then out into the room. Some people will call Class II Biological Safety Cabinets (BSCs) "Vertical Flow" cabinets although that is technically incorrect.

The most common reference standard for clean benches is Federal Standard 209-B which covers Clean Room and Work Station Requirements, Controlled Environment. This standard was published in 1973 and contained many useful definitions particularly of Air Cleanliness Classes. Federal Standard 209-B was superseded by 209-C and D. The most recently published standard is FS 209-E, which was officially sunset in November 2001. Federal Standard 209-B is still used today, since it was the last FS 209 to include recommendations for air velocity testing and HEPA filter leak testing in an appendix titled "Nonmandatory Supplemental Guidance Information". On page 18, section 40.3.5, FS 209-B recommends 90 feet per minute average, and uniformity within ± 20 % across the entire area of the air exit. This has been interpreted over the years to mean the air velocity average should be between 72-108 feet per minute. Section 50.1 (a) on page 18 discusses in-place filter testing for HEPA filters and recommends that no penetrations exceed 0.01% of upstream smoke concentration. A more current standard addressing clean air workstations is the Institute of Environmental Sciences and Technology (IEST) Recommended Practice, IEST-RP-CC-002.3 for "Unidirectional-Flow, Clean-Air Devices".

The Institute of Environmental Sciences and Technology Recommended Practice, IEST-RP-CC-002.3 for "Unidirectional-Flow, Clean-Air Devices" defines laminar flow equipment as: clean benches; clean work stations; wall and ceiling-hung modules; and other laminar flow clean air devices with self-contained motor-blowers.

Like Biological Safety Cabinets, most manufacturers recommend annual testing and certification. Different types of users may need to meet industry or regulatory certification requirements. The Joint Council of Accredited Hospital Organizations (JCAHO) recommends certifications at least annually in health care organizations. USP 797 requires Compounding Pharmacy's to be certified semi-annually. IEST-RP-CC-002.3 recommends testing at "regular periodic intervals, at a frequency consistent with location, function, and established guidelines", and "following potentially disruptive events, such as relocation of the device or replacement of the HEPA/ULPA filters".

IEST-RP-CC-002.3 recommends the following tests for certification in the field: Air Flow Velocity; HEPA/ULPA Filter Installation Leak Test; Induction Leak Test/Backstreaming Test (when appropriate); Lighting Level (when appropriate); Noise Level (when appropriate); Vibration (when appropriate). The "when appropriate" clauses recognize the necessary testing differences between a horizontal flow clean air bench and a ceiling-hung laminar flow module that is 8 feet off the floor.

Laminar Flow units can be affected by the same problems as biological safety cabinets, i.e., incorrect location in the work room, in proximity to high traffic areas or doors, room ventilation problems, or building electrical limitations.

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Aseptic Compounding Isolators (CAI's & CACI's)

There are two types of Isolators.