HVAC instructions in GMP EU guidance.
The HVAC instructions in the EU GMP will help businesses to complete the air conditioning system of factories and drug storage warehouses in order to meet the standards of good manufacturing practice.
A large-scale pharmaceutical and food supplement factory requires a standard air-conditioning system. HVAC is an air conditioning system, aiming to manage the air quality in the production and storage areas of medicines up to standards. HVAC instruction in GMP EU guidance will help businesses perfect the best air supply system in the environment of drug and pharmaceutical production.
The role of the HVAC systems in GMP EU guidance
EU GMP standards allow pharmaceuticals and functional foods to have the opportunity to access European markets, increasing competitiveness in bidding projects in hospital pharmacies.
Air quality management HVAC system in GMP EU guidance
The EU GMP standard helps to strictly manage and evaluate the factory cleaning process. Laboratory space, drug production, finished products packaging … to be cleaned of bacteria, free of contaminated ingredients, which increases the risk of cross-contamination, negatively affecting drug quality.
Air is a large environment, directly affecting the factory space, cleanroom for research and drug production. Bacteria can enter through the air, bringing potential pollutants into the factory, contaminating the space that has been cleaned and disinfected. HVAC systems is the abbreviation of factory air conditioning system (Heating, ventilation, and air conditioning)
, which plays an important role in controlling the air quality in the building space. The HVAC systems in GMP EU will control factors: temperature, humidity, dust concentration, number of microorganisms, pressure inside the workshop space. This plays an important role in the cleaning process of the factory, minimizing the effects of pollution on factory equipment, raw materials, and medicinal products.
Functions of HVAC systems in GMP factory
The HVAC systems include: heating, ventilation and air conditioning systems that manage and control air quality in drug manufacturing plants. HVAC systems adjust and create a clean level for each area, according to GMP cleanroom standards: laboratory areas, drug production sites, transportation lines, packaging and drug storage…
HVAC will control factors: temperature, humidity, dust concentration, number of microorganisms, pressure … in the production area, laboratory area, warehouse area and packaging area in the factory that acc. to GMP EU guidance.
It can be seen that the HVAC systems play an important role in operating the drug factory according to GMP EU standards. Although GMP standards are quite strict in assessing cleanroom level, however, depending on each drug, the production process will have its own requirements for room cleanliness (For example, infusion drugs require Class A cleanroom, however the production of oral tablet form only requires a Class D cleanroom).
HVAC systems constructing instructions in GMP EU guidance for medicinal factories.
Enterprises need to build and complete a GMP EU factory, in which the HVAC systems play an important role, helping to control the cleanliness of the environment inside the production area. HVAC systems design in GMP EU includes: AHU air handling unit, air conditioning system – CDU outdoor unit, ventilation control system – adjustment valve, sound absorber, HEPA filter with filtration levels different for each region.
In particular, the appraisal of HVAC systems in GMP EU guidance should note the following stages:
- Evaluation of installation of HVAC – IQ systems.
- Check and verify the operability of the HVAC – OQ systems.
- The operating system ensures that the specifications are within the intended range for the production plant.
- Check the operability, integrity of the HEPA filters, with the DOP test (0.3 micron).
- Measure and check the average speed of air flowing through the end filter.
- Check the average air flow in the system, 10% error within design range.
- Test the humidity maintained in each room, for 3 consecutive days.
- Check the air flow pattern, according to the EU GMP clean level standard.
- Check the AHU system, fan, radiator working as designed.
- Check for errors when operating the HVAC system during the appraisal period.
Enterprises which want to design HVAC systems to meet GMP EU standards need to understand the acceptable standards of the factory system. Intech, a unit specializing in the design of HVAC systems for GMP EU factories, will advise and provide design solutions for the air management system of pharmaceutical factories according to the most stringent standards.
The HVAC systems will control dust concentration, ensure management and supply of clean air that meets standards for production areas, inspection laboratories, drug samples, storage areas… HVAC guidelines in GMP EU guidance will help businesses to install an air control system for a drug factory that adheres to the principles of good manufacturing practice.