Medical Device Manufacturing is highly regulated by the FDA standard, as there are many patients got infected by impuri- ties chemical from the medical device. The medical device is classified to class 1, class 2 and class 3. The classification is de- fined by the risk of device failure that could harm to an end user; however, every class should be controlled under the FDA standard.

QV Test’s comprehensive cleanroom and controlled environment validation services coupled with our technical expertise and regulatory knowledge will ensure your critical environments are in compliance with the standard and regulation needed to enhance your operation quality.

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 sys- tems, clean steam systems used to sanitize product containers or product mixing vessels, and air and gases that contact product.

• Cleanroom Validation :

  Controlled environments play a critical role in ensuring that products meet or exceed quality and regulatory standards.

  To show that a cleanroom is working satisfactorily, it is necessary to 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 con taminated 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 concentrations of contamination.

  QV test offers the test includes :
  Primary Tests are related to 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 test includes:

  • - Airflow Velocity and Uniformity Tests
  • - HEPA Filter Installation Leak Tests
  • - Magnehelic Gauge Verification
  • - IQ/OQ Preparation and Execution
• 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 collecting dust, particle and other impurities from air or gas. The operation validation will be conducted by studying airflow velocity and direction profile, which could be verified by smoke studies. Also, air pressure measurement is also one of the parameters for this test.

  QV Test offers the test includes :

  • - 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, Cool Storage, and Warehouse :

  The purpose of validating environmental control unit is to ensure that the temperature and humidity level could be maintained within the requirement in the period of extremes condition of external. The validation could help customers to study the hot spots and cold spots in the system and research for the recovery time in case that there are excursions happened.

  QV test offers service includes :

  - Temperature Mapping Studies / Temperature & Humidity Mapping Studies.

Equipment Qualification

• Laminar Airflow Unit

  Laminar airflow unit is an area that is controlled the airflow pattern to be laminar, as it is highly likely that with unidirectional airflow could lower the risk of contamination in orderly pattern. Conversely, turbulent air flow pattern could not be controlled, resulting to have high risk of contamination.

  

  The procedure of validation will be the same as individual cleanroom consist 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 the operators to be affected by the contamination. QV test conducts the test by referring to 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
• ETO Sterilizer

  Ethylene Oxide (ETO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization such as devices that incorporate electronic components, plastic packaging or plastic containers.

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

  QV test offers service includes :
  - Temperature Mapping Studies / Temperature & Humidity Mapping Studies.