How To Choose A Pharmaceutical Clean Room? Comprehensive Analysis of The Classification And Design Points of Pharmaceutical Clean Room

In high-precision industries such as chip manufacturing and medical devices, clean rooms are undoubtedly the core of infrastructure. In the pharmaceutical industry, cleanliness requirements and grade requirements are more stringent. Because Pharmaceutical Clean Room is not only related to the cleanliness of the production environment, but also directly related to the quality, safety and GMP compliance of drugs.

Especially in the fields of sterile preparations, vaccines, biopharmaceuticals, etc., particles and microorganisms in the production environment must be strictly controlled, otherwise it will seriously affect the stability and safety of drugs. Therefore, different production links need to be equipped with different levels of Clean Room System to adapt to their process requirements. For example, aseptic operation areas such as liquid filling must be in Class A environment, while the liquid preparation area requires Class B or Class C environment for support.

This also means that the level of pharmaceutical clean room not only affects the design plan and construction cost, but also directly affects the equipment configuration, maintenance system and future audit risks. If the level is not set properly in the early planning, it will not only lead to high costs for re-rectification, but also may delay the entire production cycle.

How are pharmaceutical cleanroom grades and classification standards divided?

At present, the pharmaceutical industry generally refers to two sets of standards to determine cleanliness levels:

ISO 14644 series international standards: ISO 1~9 grades are divided according to the number of suspended particles.

GMP standards: With microbial control capabilities as the core, they are divided into four grades: A, B, C, and D.

Although the two systems have different focuses, they are often used in combination in actual applications. The following are common grade comparisons and application scenarios:

For example: In the production of injections, from solution preparation, filtration, filling, sealing to finished product packaging, each link must match the corresponding cleanliness level, otherwise it will not only fail to pass the GMP certification, but may also lead to product contamination, recall or even suspension of production.

With the popularization of Modular Cleanroom Systems, pharmaceutical companies can more flexibly design modular partitions for clean spaces of different levels, which not only meets GMP compliance, but also improves construction efficiency and maintenance convenience.

Three things to note when planning a Pharmaceutical Clean Room

A clean room system that truly meets pharmaceutical needs must not only meet technical specifications, but also take into account future operational efficiency. The following are three key planning points summarized by our Amber Team in 17 years of project experience:

1. Formulate a level strategy based on process requirements to avoid "high configuration and low use"

The higher the level, the better the clean room. When we took over the early planning of the customer, we pursued "full plant A level", but the operating energy consumption was extremely high, the equipment frequently alarmed, and there was no actual output gain. A reasonable strategy should sort out the needs one by one according to the production process, accurately place the clean level in the key area, and achieve "high when it should be high, and save when it should be saved".

We support customers in providing early process-level matching consulting services to help projects clarify space level planning in the early stages.

2. Reasonably design the flow of people and logistics routes to eliminate the risk of cross-contamination

The flow path of personnel, materials, and waste is one of the core of clean room design. In the Pharmaceutical Clean Room project, if the flow of people and logistics is not designed reasonably, it is very easy to cause cross-contamination and increase audit and quality control risks.

During the design phase of the Clean Room System, we will draw a schematic diagram of the flow of people and goods for customers, and recommend the configuration of key equipment such as air showers, transfer boxes, buffer zones, etc. to ensure effective isolation and stable airflow between clean areas.3. Focus on long-term operating costs and maintenance convenience

Operating a clean room is far more important than building it. Compliance with temperature and humidity control, positive pressure difference management, environmental monitoring and HEPA filtration systems are all indispensable parts of the clean room system. We use a high-efficiency FFU air supply system with a real-time environmental monitoring module to ensure long-term stable operation of the clean environment and reduce energy consumption costs.

At the same time, under the Modular Cleanroom Systems architecture, if the company's production capacity is adjusted or the process is changed in the future, only partial disassembly or re-layout of the modules is required, which greatly reduces the adjustment cost.

Conclusion

The construction of a pharmaceutical clean room is a systematic and refined project. It is not only the gatekeeper of product quality, but also the core asset of corporate competitiveness. Building a scientific, compliant and scalable Pharmaceutical Clean Room is a necessary strategic investment.

If you are planning a new project, or encounter problems such as unclear cleanliness level and unreasonable layout, please feel free to contact us. With 17 years of industry experience, we will provide you with personalized customized solutions, from design drawings, module manufacturing to on-site construction, full-process services, to help every pharmaceutical space to comply with regulations and achieve safe production.