Bio/Pharmaceuticals is the business of delivering safe and effective drugs to the marketplace while ensuring the health andwell-being of personnel, all in a heavily regulated environment with exacting quality standards.

QV Test’s comprehensive cleanroom and controlled environment validation services coupled with our technical expertiseand regulatory knowledge will  ensure the critical environments are performing in accordance with international standards, regulations, and customer quality specifications. 

Facilities and Utilities Qualification

Qualification studies are required on critical utilities, not on all utilities. A critical utility is one that has direct product contact,or that impacts the product. If a utility has product contact, it is critical and will be validated. Examples are purified water systems, clean steam systems used to sanitize product containers or product mixing vessels, and air and gases that contact product. 

• Cleanroom Validation
  

   Most of the operation in Bio/Pharmaceutical Industry have  to be performed under clean room validation.

  To show that a cleanroom is working satisfactorily, it is necessary  that demonstrate that the following principles have been satisfied :

  • ‐ The air supplied to the cleanroom is of sufficient quantity to dilute or remove the contamination generated in the room.
  • ‐ The air supplied to the cleanroom is of a quality that will not add significantly to the contamination within the room.
  • ‐ The air within the cleanroom suite moves from clean to less‐clean areas to minimize the undesirable movement of contaminated air. Air should move in the correct direction through doorways and the construction fabrics of the room.
  • ‐ The air movement within the cleanroom should ensure that there are no areas within the room with high concentrationsof contamination.

  QV Test offers the following  :
  
  Primary Tests are related to the airborne particulate cleanliness class as required by ISO 14644. By performing these tests,the cleanroom will be correctly classified to the appropriate class level

  • - Airflow Velocity and Uniformity Tests
  • - Airflow Volume and Uniformity Tests
  • - Air Change Rate (ACH) Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Room Pressurization Test

  Secondary Tests are user optional and relate to particle, air movement, and ancillary systems within the cleanroom

  • - Airflow Smoke Pattern Tests
  • - Recovery Tests
  • - Lighting Level and Uniformity Tests
  • - Temperature and Humidity Uniformity Tests
• HVAC System: Air Handling Unit (AHU) Validation

  The heating, ventilation and air conditioning (HVAC) system that supports cleanrooms must be qualified.

  QV test offers the following :

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Magnehelic Gauge Verification
• Dust Collector System Validation

  Dust collector is a system to collect the dust from the released air from the operation of the production line, by collectingdust, particle and other impurities from air or gas.

  The operation validation will be conducted by studying airflow velocity and direction profile, which can be verified bysmoke studies. Air pressure measurement is also one of the parameters for this test.

  QV Test offers the following  :

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Room Pressurization Tests
  • - Airflow Smoke Pattern Tests
• Environmental Control Unit Validation: Cold Room System, Stability Room/Chamber, Incubator Room, CoolStorage, and Warehouse :

  The purpose of validating  an environmental control unit is to ensure that the temperature and humidity level can be maintained within the requirement during any periods  of extreme condition of external. The validation could help customers to studythe hot spots and cold spots in the system and research for the recovery time in case  excursions do happen.

  QV Test offers the following :

  - Temperature Mapping Studies / Temperature & Humidity Mapping Studies.

Equipment Qualification

• Laminar Airflow Unit

  Laminar airflow unit is an area that  controls  the airflow pattern to be laminar, as it is highly likely that  unidirectionalairflow can lower the risk of contamination in an orderly pattern. Conversely,  a non- unidirectional airflow  pattern cannot be controlled,resulting in a high risk of contamination.

   The procedure of validation will be the same as for an  individual cleanroom and consists of :

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Differential Pressure and Magnehelic Gauge Reading
  • - Airflow Smoke Pattern Tests

  Normally, Laminar cabinet cleanliness class is “A” or class 100.

• Bio Safety Cabinet (BSC)

  There are three types of BSC, class I, II and III to protect operators being affected by  contamination. QV Test conducts the tests by referring to the GMP standard.

  Test parameters

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Airborne Particle Count Cleanliness Classification Tests
  • - Differential Pressure and Magnehelic Gauge Reading
  • - Airflow Smoke Pattern Tests
  • - Lighting Level and Uniformity Tests
  • - Ultraviolet light measurement
• Dry Heat Sterilizer: Hot Air Oven and Tunnel Sterilizer

  QVTest offers the following services :

  • -Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests 
  • - Airborne Particle Count Cleanliness Classification Tests 
  • - Airflow Smoke Pattern Tests 
• ETO Sterilizer
  
  Ethylene Oxide (ETO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot supportconventional high temperature steam sterilization with devices that incorporate electronic components, plastic packagingor plastic containers.

  The main physical parameter to qualify the ETO sterilization process is the distribution of temperature and relative humidity in the inchamber and product packaging.

  QV Test offers the following services :
  - Temperature Mapping Studies / Temperature & Humidity Mapping Studies.