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.

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. Most 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 recommends 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. Some State Boards of Pharmacy recommend or require semi-annual certification. For pharmaceutical applications under FDA jurisdiction BSCs tend to be certified semi-annually.

NSF International's Standard 49 recommends five containment tests for field certifications: downflow velocity profile test; inflow velocity test; airflow smoke patterns; HEPA filter leak test; and a cabinet leak test (when a cabinet is newly installed, relocated, or after panels were removed during maintenance procedures). The four worker comfort and safety tests recommended by NSF International are: electrical leakage, ground circuit resistance and polarity 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 (if present) 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 about 15 years.

We provide these services to the 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.

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 (AIHA/ANSI, 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.

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 superceded 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-002-86 for "Laminar Flow Clean Air Devices". It was published in January 1986.

The Institute of Environmental Sciences and Technology Recommended Practice, IEST-RP-CC-002-86 for "Laminar 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. For hospital applications, JCAHO goes along with that for the most part. Pharmaceutical companies under FDA jurisdiction are required to perform semi-annual certification. Some State Boards of Pharmacy also require semi-annual certification. For R&D or electronics manufacturing use annual tests are recommended. IEST-RP-CC-002-86 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-002-86 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.

Decontamination

LTS follows industry standards and practices in using paraformaldehyde to decontaminate spaces and equipment that are microbiologically contaminated. We perform decontaminations to assure the safety of LTS and client personnel and the environment when maintenance of contamination control equipment requires accessing a contaminated area.

LTS has been performing equipment and space decontaminations for about 15 years and has decontaminated facilities as large as 150,000 cubic feet in volume.

LTS has the following policy for determining when paraformaldehyde decontamination is required:

Paraformaldehyde decontamination is required before working on any unit where biologically active agents susceptible to formaldehyde have been used and the work requires access to the filter chamber or contaminated plenum, or pressurizing a contaminated plenum that could leak to the exterior of the cabinet.

Paraformaldehyde decontamination is also required for these agents if a massive spill has occurred, if the agent requires BSL-3 or BSL-4 containment, or if the agent requires BSL-2 containment and is used in non-diagnostic work (i.e., in large quantities).

LTS utilizes two different methods of neutralizing formaldehyde. Our standard practice for neutralizing Class IIA biological safety cabinets is to use ammonium carbonate, however, when requested LTS will utilize a potassium permanganate filter over the cabinet's exhaust filter. This process minimizes unpleasant odors and cabinet clean-up requirements. When neutralizing Class IIB biological safety cabinets and large spaces, we follow the industry standard practice of utilizing ammonium carbonate.

Cleanroom Certification

A cleanroom is a room in which the concentration of airborne particles is controlled to specific limits. They are classified by the numbers of particles per cubic foot per minute. Sizes of particles which are controlled usually range from 0.1 micron to 10 microns. Typical room classes (in English) are Class 1, 10, 100, 1,000, 10,000 and 100,000. Classes in ISO terms 1, 2, 3, 4, 5, 6, 7 and 8. In November 2001, the federal government decided to officially sunset Federal Standard 209, at the recommendation of the working committee for that standard. In and effort to achieve globalization of standards, the committee recommended that the federal government supercede Federal Standard 209 with ISO 14644. This was accepted by the US Government and now the same standard for cleanroom certification is being utilized world-wide.

Cleanrooms may be unidirectional (laminar), non-unidirectional (turbulent), or mixed airflow. Clients may choose from a variety of tests, depending upon their needs. A partial list from the Institute of Environmental Sciences and Technology document "IEST-RP-CC006.2 - Testing Cleanrooms" would include:

• Airflow Velocity/Volume
• HEPA Filter Leak Test
• Particle Counts
• Room Pressurization
• Parallelism
• Recovery
• Integrity
• Light Levels
• Noise Levels
• Temperature/Humidity
• Vibration

Depending upon the use of the cleanroom, testing and certification is usually performed at initial installation and at specified intervals. In the medical field, certification is performed semi-annually or annually. Electronics firms may have independent testing initially and whenever problems occur. But they are typically monitoring their rooms daily with in-house personnel.

LTS is certified in "Cleanroom Performance Testing" according to NEBB (National Environmental Balancing Bureau) and has the experience and technical knowledge to test any cleanroom in the pharmaceutical, electronics, medical and food industries.

Repairs & Maintenance

Service Agreements

Many of our customers have found a service agreement, with LTS, to be an effective tool for budgeting. With a fixed price agreement, you don't have to worry about costly repairs that you didn't budget for. With a service agreement, you can fix your costs for one, two or even three years.

In addition to a fixed cost, a service agreement eliminates the need for you to track your re-certification schedule. LTS automatically calls all customers, with service agreements, to schedule your re-certification. With so many things on your schedule today, let LTS help you eliminate the need to remember when to call for a certification.

All clients with equipment covered by an LTS Service Agreement receive guaranteed response time to service calls.

LTS offers a wide range of service agreements designed to meet our customers' varying needs. Some basic examples of our service agreements include:

• Full Maintenance Agreements - All parts and labor included for certification and repairs
• Labor-Only Agreements - Parts less than $50 and all labor included for certification and repairs
• Certification-Only Agreements - Annual certification only included

Other types of service agreements are available. Please contact us for further information and to receive a sample service agreement.

Other Services

Certification and Repair of:

• Animal Isolators
• Bactec 460
• Bag-In Bag-Out HEPA Filter Banks
• Containment Suites
• Ductless Fume Hoods
• Exhaust HEPA Filter Banks
• Filter Replacement Data
• Filter Replacement SOP's
• Glove Boxes
• HEPA Vacuums
• Isolation Chambers
• Local Exhaust Hoods
• Maintenance and Repair of Incubators
• Negative Exhaust Hoods
• Patient Isolators
• Supply Air Handler HEPA Filter Banks