HVAC Design for Pharmaceutical Facilities

The space condition in the pharmaceutical manufacturing facilities plays an important role on the production of the goods. These facilities are closely supervised by the government whereby they need to follow cGMP (current Good Manufacturing Practices). The regulation forces the manufacturers to ensure that their finished goods are safe, pure and effective. GMP ensures the quality of the goods by minimizing or eliminating contamination, mix-ups and errors.

The GMP for HVAC regulates various things starting from the selection of the building materials, flow of the equipment, personnel and products and determination of key perimeters (eg. temperature, humidity, pressure, filtration, airflow parameters and classification of clean rooms). It also controls the quality assurance, validation of the facility and documentation for operation & maintenance.

Various countries have formulated their own GMPs. In the United States, it is regulated by several documents such as Federal Standard 209, code of Federal Regulations CFR 210 & 211, etc that are regularly updated. On the other hand, the European Community has a ‘Guide to Good Manufacturing Practice for Medicinal Products’ and in the United Kingdom, it has BS 5295. In Indonesia, our GMP is using CPOB Book. GMP version from the World Health Organization (WHO) is used widely by pharmaceutical regulators and industries in various countries worldwide, primarily in the developing countries. In some countries, they follow GMP from the country of the principal technology provider. Even though there are various versions of GMP across the world, they all have one common theme.

The characteristics and performance of HVAC in the pharmaceutical facilities must have the following:

• To protect the goods from the raw materials storage, processing, primary & secondary packaging and finished goods warehouse
• To protect the personnel
• To protect the environment

The area where the materials and goods are exposed have to be classified as ‘clean area’ and it may include the following: building finishes and structure, air filtration, air change rate per hour, room pressure cascade and air flow pattern, room temperature, room relative humidity, material and personnel flow. Below is the ‘clean room’ classification guide: