How many types of clean rooms are there in the pharmaceutical industry

Clean rooms play a vital role in the Pharmaceutical industry. They provide a clean environment for the production and development of drugs to prevent contamination and ensure the safety of products. According to international standards and industry needs, there are many types of clean rooms, which are mainly classified according to their cleanliness level, purpose and design. This article will explore the common types of clean rooms in the pharmaceutical industry and their characteristics.

Classification by cleanliness level

Clean rooms are usually classified according to their cleanliness level, and the most commonly used standard is ISO 14644-1. According to this standard, the cleanliness level of modular clean rooms is divided into ISO 1 to ISO 9, among which ISO 1 is the cleanest level, with a very small number of particles allowed in the air, suitable for high-end pharmaceutical and biotechnology fields. ISO 5 Clean rooms, which are usually used for the production of sterile drugs, have a particle count of no more than 3,520 per cubic meter. According to different production needs, pharmaceutical companies will choose clean rooms of different levels.

Classification by purpose

Clean rooms in the pharmaceutical industry can also be classified according to their purpose, including R&d Clean Rooms, production clean rooms, and inspection clean rooms. R&D clean rooms are usually designed to ISO 7 or ISO 8 levels, suitable for preliminary drug development and formulation testing. Production clean rooms must meet higher cleanliness standards, usually ISO 5, to ensure the sterility of drugs during the production process. Inspection clean rooms are mainly used for quality control of drugs, usually ISO 6 or higher.

• R&d CleanRoom: ISO 7 or ISO 8

• Production cleanroom: ISO 5, to ensure drug sterility

• Inspection cleanroom: ISO 6, for quality control

Classification by design type

There are many types of Cleanroom designs, the most common of which are single cleanroom and multi-cleanroom. Single cleanrooms are usually used for small-scale production or specific experiments, with an area of 20 to 100 square meters. Multi-cleanrooms are suitable for large-scale production, usually consisting of multiple independent cleanroom areas, with an area of up to hundreds of square meters. This design can not only meet the needs of different production processes, but also improve production efficiency and flexibility.

Cleanrooms for special applications

In addition to conventional cleanrooms, there are also some cleanrooms for special applications in the pharmaceutical industry, such as biosafety cleanrooms for biopharmaceuticals and special cleanrooms for radiopharmaceuticals. Biosafety modular cleanrooms usually need to meet BSC (biological safety cabinet) standards to ensure the safety of operators and the environment. Cleanrooms for radiopharmaceuticals must meet specific safety standards to prevent radioactive contamination and ensure the safety of staff.

• Biosafety cleanroom: meets BSC standards

• Radiopharmaceutical cleanroom: special safety standards

• Special applications meet specific industry needs

Future trends in cleanrooms

With the continuous development of the pharmaceutical industry, the design and technology of cleanrooms are also evolving. Cleanrooms in the future will focus more on intelligence and automation, such as using IoT technology to monitor air quality and energy consumption in real time. In addition, environmental protection and sustainability will become important considerations in cleanroom design, using more efficient air filtration and circulation systems to reduce energy consumption and operating costs.

• Intelligence: IoT real-time monitoring

• Environmental protection: High-efficiency air filtration and circulation system

• Sustainability will become a new design trend

List of relevant standards and specifications

• iso 14644-1: Cleanrooms and controlled environments Part 1: Classification of air cleanliness

• GMP (Good Manufacturing Practice) Guidelines

• IEST-STD-CC1246D: Testing Cleanrooms