It is defined as the process of independently testing and proving the accuracy, reliability and repeatability of the facility and its design, systems (HVAC / water / compressed air etc.), equipment, process, product.
It is to prove with highly reliable documents that a specific process will operate consistently in accordance with predefined specifications and quality values.
Even though clean rooms are validated and their effectiveness is periodically monitored, the working conditions inside and the biological impact of factors outside the clean room on these systems should also be checked. For this reason, swap samples are taken from the air, surfaces (tables, equipment, etc.) and the clothes and hands of the working personnel to check the level of viable microorganisms.
The results of biocontamination will have a positive or negative impact on the bioburden of products produced in the cleanroom. Therefore, product cleanliness is closely related to the cleanliness of the air, surface and personnel.
ISO 14698-1 Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods
ISO 14698-2 Cleanrooms and associated controlled environments — Biocontamination control– Part 2: Evaluation and interpretation of biocontamination data
GMP ANNEX-1
Autoclaves are validated according to EN 13060 and EN 285 standards. After the studies to be carried out in your facility, the samples collected are analysed in our laboratories and all results are reported.
We will perform the following steps for the autoclave validation study;
This work is carried out as proof of successful sterilization of products that are placed on the market as sterile or placed on the market as non-sterile and sterilized before use.
We are performing a steam sterilization validation study with the following steps,
Steam sterilization validation, TS EN ISO 17665-1- Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
Clean Rooms; These are special rooms where the concentration of particles flying in the air is kept under constant control by measurements, built and used in a way to minimize particle entry, particle proliferation and particle harboring, and where other variables such as temperature, humidity, pressure, air flow patterns, etc. are kept under control to the extent necessary.
Today, clean room systems are among the priority requirements in many fields such as Human Health Activities, Biomedical Industry, Pharmaceutical Industry, Veterinary Medicine, Food Industry, Chemical Industry, Semiconductor Industry, Conductor Industry, Electronics Industry, Optical Production Industry, Aviation and Defense Industry, Biotechnology etc.
HVAC performance tests alone cannot be considered as Clean Room Validation. HVAC performance tests take place within the framework of PQ (Performance Qualification), which is part of the testing and inspection processes carried out within the scope of Clean Room Validation. In fact, Clean Room Validation has an extremely broad content that includes evaluation studies such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification).
It means “VALIDATION” and includes the validation of all stages (design, installation, start-up, functional characteristics, operation, performance, maintenance & operation, personnel training, etc.) from the design stage to the final result in order for the system to fulfill the user requirements.
During the installation of HVAC systems in qualified areas such as clean rooms and sterile areas, the main mistake made by non-professional teams is that performance tests are considered as clean room validation. Unless the above-mentioned basic verification stages of HVAC systems are performed, the fact that a newly installed ventilation system has successfully passed the performance tests is often repeatable and does not mean that successful results will be obtained consistently throughout the year.
TS EN ISO/IEC 17020 Conformity assessment — Requirements for the operation of various types of bodies performing inspection
TS EN ISO 14644-1 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
TS EN ISO 14644-2 Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
TS EN ISO 14644-3 Cleanrooms and associated controlled environments — Part 3: Test methods
IEST-RP-CC006.3 Testing Cleanrooms
IEST-RP-CC034.3 Hepa and Ulpa Filter Leak Test
VDI 2083-Part 3 Cleanroom Technology Metrology and Test Methods
Eudralex Volume 4 Medicinal Product for Human and Veterinary Use Annex 1
FDA c GMP Sterile Drug Products Produced by Aseptic Processing
DIN 1946-4 Ventilation and Conditioning-Part 4: VAC Systems in buildings and rooms used in the health care sector
Laminar Flow (LAF) Cabinets operate only for the purpose of providing protection for the product being tested. The LAF Cabinet is not used for biohazardous or chemically hazardous products as it emits process air to the personnel (operator) and the environment while performing this process.
When there are infectious particles (particles) floating in any hazardous air, it does not protect the personnel (operator) from these particles (particles). Instead, it causes these hazardous particles to contaminate the personnel (operator) or the environment.
Operation and Performance Verification Tests listed for Laminar Flow (LAF) Cabinets are carried out in accordance with EN ISO 14644-3:2005, EU Guidelines to GMP:2015 measurements and instructions.
The purpose of biosafety safety cabinets is to reduce the danger to the user when working with dangerous or potentially dangerous microorganisms. These cabinets do not necessarily protect the user from all hazards. In some types of safety cabinets, the purpose may be to protect the materials used from environmental contamination. Measurement and verification tests are required to ensure minimum performance criteria for safety cabinets working with microorganisms, to protect the environment and the worker, to protect the product and to prevent cross-contamination.
Operation and Performance Verification Tests specified for Biosafety Cabinets are carried out in accordance with TS EN 12469:2004, ANSI/NSF 49:2014 standards.
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