We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us. Airocal performs the HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.


Airocal has understood the importance of product risks by monitoring the air against quality standards, testing, giving accurate results and advising the risk factor to the clients. Testing and monitoring of compressed air and other process gases such nitrogen, oxygen, argon and carbon dioxide that come into direct contact with pharmaceutical products is vital to assuring the quality and safety of those products. Compressed Air validation is a critical component in the production of pharmaceutical industry and effects on the quality of the end product. It is used by operatives working in a number of industrial sectors including oil and gas, Pharmaceutical, Manufacturing, nuclear, diving and in medical applications. Compression of ambient air concentrates the normal contaminants already present in the air and can also introduce other contaminants such as Oil vapor, Condensed water and Bacteria.

Airocal validate Compressed Air in all kinds of industries as the demand for compressed air quality depends on its usage, we can also validate Compressed Air in some industries where they require extremely high quality air along with Breathing Air Validation, Instrument Air Validation and Nitrogen Gas Validation.

Compressed air is air kept under a pressure that is greater than atmospheric pressure. It serves many domestic and industrial purposes. Compressed Air is a vital energy source and is utilized in multiple operations in industries. When properly treated, Compressed air is regarded as a safe, clean utility, as compared to other energy sources. Compressed provides the energy source for pneumatic conveyers that transport liquids, powders and moisture sensitive product throughout the plant.

The Quality of Compressed air is important to ensure that product is safe. The most important parameters in specifying Compressed air quality are:

• Dew Point
• Oil Content
• Particulate matter
• Moisture Content
• Viable Count.
• Carbon Dioxide
• Carbon Monoxide
• Hydrogen Sulphide
• Sulphur Dioxide
• Oxygen Level
• Nitrogen Oxide
• Appearance
• Odour
• Water Vapour

The International Standard Organisation sets quality standards for Compressed air as ISO:8573.


Recently, Computerized Systems (CS) using Programmable Logic Controllers (PLC) have been utilized for controlling drug manufacturing equipment (hereafter, manufacturing equipment). Such a CS is referred to as a PLC-Based CS (PBCS). Upon the use of PBCS, the regulatory authorities require drug manufacturers to prove that their CS has adequate functions and performance. Along with the sophistication of manufacturing equipment functions, the PBCS functions have also become complicated. This has made it difficult to prove the adequacy of the functions and performance.

In this research, we propose methods for proving the adequacy of the functions and performance of PBCS with complicated structures. Drugs are essential for maintaining human life and health, while they have significant influence on the human body. This requires proper quality of drugs medicines. In order to produce drugs with proper quality, appropriate production processes are necessary in addition to use of proper raw materials and their blending percentage. Drugs have been produced manually in the past. Recently, however, they are produced by production facilities that are automatically controlled by CS in order to enhance production efficiency. Therefore, proper workability and operability of CS has become more important.

On the other hand, there exist issues that poor quality drugs are produced due to the malfunction of CS. For this reason, the regulatory authorities required drug production companies to prove that their drug production processes and CS that controls such processes are adequate to produce high-quality drugs by showing evidence based on documents or electronic data regarding drug development and verification. The procedure that proves the adequacy of the production processes is referred to as Process Validation (PV), while the procedure that proves the adequacy of the CS used for production is referred to as Computerized System Validation (CSV). Usually, PV and CSV procedures are implemented in a parallel manner along development when production facilities are built. At first, the CSV standards are stipulated according to each country that produces and sells drugs. Therefore, export of drugs on which CSV is conducted in accordance with the export country requirements must also be conducted again to meet the CSV standards of the importing country.

Since a lot of labor is needed to conduct CSV, this has actually produce significant work load on drug production companies. Therefore, the International Society for Pharmaceutical Engineering proposed CSV standards that incorporate the CSV standards of each country. These standards are referred to as the Good Automated Manufacturing Practice (GAMP). Implementation of CSV in accordance with GAMP makes it comparatively easier to export drugs to other countries. Therefore, GAMP has become the de facto CSV standard.

Currently, the fifth edition of GAMP is being used. As mentioned earlier, the production processes of drugs have become complicated, and the functions of PBCS to correspond to this situation have also become complicated. In order to achieve complicated functions, PBCS has been developed by combining the following software programs: Packaged software that cannot be modified, configurable software, and individually-developed software. However, GAMP did not include any descriptions regarding CSV for CS with such complicated structures. Therefore, this has made it difficult for drug manufacturers to conduct CSV. Manufacturing equipment will be used for a longer period of time once it has been developed and built. During the period of operation, various processes, facilities, and PBCS are modified. With respect to CSV, when modification is done, the functions and performance of the modified part needs to be confirmed immediately, and their adequacy also needs to be proved.

Additionally, the modified functions might have influence on other functions. However, it has become difficult to understand the accurate range of this influence. These facts have caused various problems to drug manufacturers regarding the implementation of CSV for PBCS.