Certification and Testing

Certification
Quality Solutions provides the following certification services from experienced staff. We customize certification testing that meets USP<797>, and other corresponding requirements. When it comes to service, Quality Solutions offers general repairs as part of the certification price. QS staff works to avoid expensive, add on repeat visits that increases your true price of certification.

Note: Mandatory USP<797> Compliant Cleanroom Tests for Testing of Primary Engingeering Controls (PEC)

Biological Safety Cabinets
  • In addition USP<797> requires: Non-viable airborne particle count testing
  • In addition USP<797> requires: Class II, Type A2 Biological Safety Cabinets must have canopy style exhaust connection
  • In addition USP<797> requires: Biological Safety Cabinet exhaust fan(s) must be direct drive type
Laminar Flow Hoods – see certification section for testing procedures All ISO 5 or cleaner devices such as sterile compounding robots.



Laminar Flow Hoods/Clean Benches
Laminar Flow Hoods or Clean Benches are used in critical environments to protect product from contaminants. They are designed to protect the product, not for operator protection. In accordance with regulatory standards, Laminar Flow Hoods must be certified at time of installation and at semi-annually thereafter. In addition, re-certification must be performed whenever HEPA filters are changed, repairs are made, or bench is relocated.

Tests include:
Air velocity (face velocity) test
HEPA filter leak/challenge test
Non-viable airborne particle count
Smoke Pattern Testing

NOTE: If Laminar Flow Hoods are Primary Engineering Control devices as part of an USP<797> Compliant Pharmacy Cleanroom Environment, they shall be certified at least semi-annually.

Guidance References: IEST, USP<797>


Biological Safety Cabinets (BSC)
Biological Safety Cabinet Primary Tests
  • Downflow velocity profile
  • Inflow face velocity test
  • Airflow smoke pattern test
    • Downflow test
    • Viewscreen retention test (pass or fail)
    • Work opening edge retention test (pass or fail)
    • Sash seal test (pass or fail)
  • HEPA filter leak/challenge test
  • Site installation assessment tests (only done if cabinet is new or moved)
In addition USP<797> requires:
  • Non-viable airborne particle count testing

Supply HEPA Filter Leak Testing
HEPA (High Efficiency Particulate Air) Filters are used in applications where the cleanest of air is required. By definition, a HEPA filter is a dry type filter in a rigid frame, having a minimum particle collection efficiency of 99.97% on 0.3 microns particles of Poly Alpha Olefin (PAO) or similar non-carcinogenic chemicals.

In accordance with regulatory standards,

Primary Tests
  • Upstream aerosol challenge concentration
  • Acceptable design leakage percentage
  • Actual leakage measured
  • Pass or fail
Guidance References: IEST, USP<797>


Cleanroom Certification- Primary Cleanroom Tests
Primary Cleanroom Tests
  • Testing of Primary Engineering Controls (PEC) or containment devices within the cleanroom space(s): Biological Safety Cabinets, Laminar Flow Hoods, Chemical Fume Hoods, etc.
  • HEPA Filter Leak / Challenge Testing
  • Airflow Velocity / Volume Testing
  • Room Air Change Rate(s)
  • Room Differential Pressure Testing
  • Temperature / Relative Humidity Testing
  • Non-Viable Airborne Particle Count Testing
  • Airborne & Surface Viable Particle Sampling
Guidance References: USP<797>, CETA CAG-003 Certification Application Guide for Sterile Compounding Facilities.


Aseptic Isolators, Gloveboxes, Containment Isolators Testing & Certification
Aseptic Isolators play an important role in compounding pharmacy. They are designed to protect the product or process, not for operator protection. An isolator separates a product or process from its production equipment, technical personnel, and surrounding work environment. They are used in applications requiring a high degree of protection from external elements or contaminants, and they can also serve as alternatives to sophisticated cleanrooms. As a result Isolators need specific procedures for cleaning and operation to ensure they are maintaining and aseptic environment during transfer and CSP production.

Isolators are usually equipped with air filtration systems capable of lowering a particle count in an enclosed area. A positive air pressure is maintained to prevent contaminants from entering the device, while work is done through sealed glove assemblies.

In accordance with regulatory standards, Compounding Aseptic Isolators must be certified at time of installation and at least semi-annually thereafter. In addition, re-certification should be performed whenever HEPA filters are changed, repairs are made, or the isolator is relocated. More frequent re-certification intervals should be considered for particularly hazardous or critical applications or workloads. Furthermore, Quality Solutions treats each isolator as a miniature cleanroom environment and therefore provides viable testing based on the chambers application.


Isolator Primary Tests
  • Airflow (velocity) tests – The following must be performed for each: Main Work Chamber
  • Pass-through Chamber
  • Egress Opening
  • Pass-through Opening
    • Chamber Pressure Testing – Main Chamber & Pass-through.
    • Site installation assessment tests
    • HEPA filter leak/challenge test (Integrity Test)
    • Airflow smoke pattern test
    • Non-viable airborne particle count test
    • 2.06- Particle Contaminant Inegrity and Enclosure Leak Test
    • 2.09 Ingress/Egress
    • Viable Surface Sampling
    • Viable Air Sampling
There are additional tests recommended by CETA and may be performed based on client request.

In addition, Isolators require environmental sampling plan to ensure that they maintain an aseptic environment for CSP production. Quality Solutions works with our clients to develop and appropriate sampling plan based on the individual equipment and its use in the compounding pharmacy.

Guidance References: CETA, USP<797>, and IEST


Visual Airflow Characterization (Smoke Studies)
Quality Solutions staff can visually characterize the predominant airflow direction at multiple locations throughout, and contiguous to, the work zone or critical areas within the cleanroom. The test verifies that a cleanroom is capable of controlling dispersion of the air stream and therefore verifying that critical areas of the cleanroom where critical processes take place are not negatively impacted by equipment placement or airflow patterns in the room.


Equipment Repairs
Our certifying technicians have extensive experience in testing, troubleshooting, and repairing laminar flow equipment. With this diverse experience our engineers and technicians can handle the newest advances in Laminar Flow technology and add value by sharing our experience with clients.


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