Conditions of clean rooms:
- Asbuilt
The premises are fully assembled. Engineering systems are connected. No equipment, materials or medical personnel are not present.
- At rest
The premises are fully equipped with operational equipment. Medical personnel are not present.
- Operational
The facility is functioning as intended. Medical personnel are performing standard work operations.
Climatech Engineering performs a full range of services for the qualification of engineering systems, clean rooms in medical and preventive care facilities (MPCF), and clean areas.
Qualification services are provided at all stages — DQ, IQ, OQ, PQ.
- Design Qualification (DQ) — an examinationaimed at confirming the compliance of design planning and technological solutions, decisions on the configuration and composition of engineering systems with established norms and rules. It also includes an overall assessment of the correctness of the design documentation in accordance with the medical and technological design specifications approved by the customer.
- Installation Qualification (IQ) — documentaryconfirmation of the full compliance of the installedstructural elements, main and auxiliary engineering equipment of clean rooms in medical institutions with the design documentation.
- OperationalQualification (OQ) – a set of tests, control measurements and a conclusion on the correctfunctioning of engineering systems and installed engineering equipment.
Documentary confirmation that the internal air environment conditions of the clean room are reliably maintained and guaranteed to ensure the performance of the functions specified in the design within the planned scope of technological operations.
- Performance Qualification (PQ) – documentaryconfirmation of the normal operating modes of the main engineering systems of the clean room in the healthcare facility. Full compliance with the required cleanliness class, as well as the general declared technological parameters.
Proof and documentary confirmation of the reliability and reproducibility of the operating parameters of the clean room in the healthcare facility through tests involving simulated or real technological processes and manipulations inside. This stage of qualification is carried out directly in the working area, i.e. in the area where there is open contact with the environment.
The main types of work performed to certify clean rooms in healthcare facilities (depending on the stage of testing):
- Checkingthe availability and completeness of documentation for clean rooms and ventilation and air conditioning systems;
- Assessment of the completeness of the main and auxiliary engineering equipment of the clean room;
- Inspection of the supply of all energy carriers and technological media (electricity, steam, water, compressed air, gases, etc.) in accordance with the project specifications;
- Checking the calibration (verification) dates of all control, monitoring, warning and alarm systems;
- Checking the quality of the installation of clean room structuralelements and engineering equipment;
- Tightness of clean room enclosingstructures;
- Measuring the volume of air supplied and removed per unit of time, calculating the air exchange rate;
- Measuring the speed and determining the uniformity of laminar air flow;
- Measurement of temperature and relative humidity;
- Measurement of pressure differences, air flow control (visualisation of flows);
- Checking the integrity and tightness of the installation of high-efficiency air filters;
- Measuring the particlecount concentration of aerosol ranging in size from 0.3 to 10.0 microns;
- Determining the time required to restore the cleanliness class (decontamination time);
- Additionaltests: (illumination, noise, vibrations, etc.).
The scope of testing for room qualification is determined based on established regulatory documentation and the Customer’s internal instructions, analysis of critical conditions and parameters, as well as the “worst case” scenario for equipment operation.
Climatech Engineering specialists have all the necessary measuring equipment at their disposal to carry out the relevant qualification activities.
Regulatory documentation:
- Non-Profit Partnership AVOK 7.8-2022 Design of engineering systems for medical and preventive institutions;
- R NP AVOK 7.8.3-20223 Design of engineering systems for laboratories;
- GOST R 52539-2006 Air purity in medical institutions. General requirements;
- SP 2.1.3678-20 Sanitary and epidemiological requirements for the operation of premises, buildings, structures, equipment and transport, as well as the conditions of activity of economic entities engaged in the sale of goods, performance of work or provision of services;
- GOST R ISO 14644-1-2017 Clean rooms and associated controlled environments. Part 1. Classification of air cleanliness;
- GOST R ISO 14644-2-2020 Clean rooms and associated controlled environments. Part 2. Routine monitoring to confirm the continued compliance of air cleanliness with particle concentration;
- GOST R ISO 14644-3-2020 Clean rooms and associated controlled environments. Part 3. Test methods;
- GOST R ISO 14644-4-2002 Clean rooms and associated controlled environments. Part 4. Design, construction and commissioning;
- ORDER OF THE MINISTRY OF INDUSTRY AND TRADE OF RUSSIA No. 916 of 14 June 2013 On the Approval of the Rules of Good Manufacturing Practice;
- MU 64-04-001-2002 Manufacture of medicinal products. Validation. Basic provisions;
- Decision of the Council of the EurasianEconomic Commission No. 77 dated November 3, 2016, Rules of Good Manufacturing Practice.
- Instruction’Procedure for Monitoring Air Parameters in Clean Rooms and Methods for Measuring Them in the Production of Medicines. RDI 42-505-00′” (approved by theMinistry of Health of the Russian Federation on December 22, 2000)
