On the one hand, according to the GMP Good Manufacturing Practice System standard, on the other hand TS 11605 EN ISO 14644-1 standardAccording to na, the golden rules for cleanroom are:

  • Preventing the entry of micro-organisms or particles into a clean room
  • Permanent removal of micro-organisms or particles to be detected in a clean room
  • Control of possible contamination and contamination sources in the clean room
  • Finding technical areas such as corridors or columns for clean room
  • Identification of materials or products to be used in the clean room or personnel to use the clean room
  • Defined closed process systems

Today in modern sense clean room Areas of use include:

  • Medical equipment, cosmetic products and food-producing organizations
  • In hospitals, operating rooms and intensive care units
  • Electronics or automotive industry
  • Laboratories

The purpose of clean room use is:

  • To ensure compliance
  • Constantly producing the same quality product or service
  • Crossing the cross
  • Ensuring the protection of the employee, product or environment

Clean room tests The design of the clean room is very important during. Clean room requirements can be listed as follows:

  • Proper ventilation system installed
  • Should be designed in terms of dimensions
  • Suitable construction materials must be used when performing
  • Appropriate equipment must be used when performing
  • Proper hygiene conditions must be met
  • The personnel who will use the clean room should be given the necessary training
  • Circulating conditions must be met

In the tests to be performed, the most emphasized points are:

  • Differential pressure measurement
  • Temperature and humidity measurement
  • Recovery test
  • Calculation of air flow rate and number of air changes
  • Hepa filter sealing test

These tests are carried out only by test and examination organizations or laboratories which have the necessary equipment. The most important issue that needs to be considered here is whether the organizations that will conduct the test are accredited. At the end of the test and examination measurements and observations, these organizations prepare a report and submit it to the company. For these reports to be valid, they must be authorized.

Testing and examination organizations or the laboratories obtain this authorization from relevant accreditation bodies. Accreditation bodies authorize organizations that they believe to have the necessary equipment to carry out tests and inspections on their own behalf and to prepare reports.

Accreditation bodies should also be convinced that these organizations will operate impartially and independently and report. This point is important as all the activities will be carried out on behalf of the accreditation body and the name and logo of the accreditation body will be used in the reports to be prepared.

The TÜRCERT certification body provides conformity assessment, certification and training services, and also provides testing and inspection services. Clean room testing is one of the services provided in this way. Please do not hesitate to contact the TÜRCERT certification body, its experienced managers and employees for more information about which organizations are doing the clean room tests.