what is a clean room in pharmacy

A Clean Room in a pharmacy is a special space. It is made to reduce airborne particles and contaminants. These special areas are important for making and mixing sterile pharmaceutical products. They ensure that the conditions meet strict cleanliness and sterility standards. Clean rooms have high-efficiency particulate air (HEPA) filters. 

They also maintain controlled temperature and humidity levels. Strict rules are in place for personal hygiene and gowning procedures. By maintaining these conditions, clean rooms help prevent contamination that could compromise the safety and efficacy of pharmaceutical products.

Why does drug production need to be carried out in a clean room environment

The drug production process has very strict environmental requirements. A clean room is essential to ensure the safety and effectiveness of drugs. The international standard ISO 14644 says that clean room air must have a controlled number of particles. This helps stop microorganisms and dust from contaminating drugs. In drug production, any slight contamination may lead to product failure and even threaten the health of patients. The clean room helps lower the risk of cross-contamination. It also makes sure the drug is safe from the outside environment during production.

Studies show that clean rooms can lower the product failure rate to under 0.1%. This greatly improves production efficiency and product quality. Aseptic operation and a clean environment are essential for drug production. They help meet GMP (Good Manufacturing Practice) requirements. China's "Good Manufacturing Practice for Pharmaceuticals" says that drug makers must create clean areas. These areas must meet certain standards to keep drugs safe and of good quality.

Functional division of clean workshops in pharmaceutical factories

Clean workshops in pharmaceutical factories are usually divided into areas according to functions to ensure the efficiency and safety of the production process. The following are common functional areas and their uses

Raw material area

This area is used to store and handle pharmaceutical raw materials to ensure that the raw materials are in a clean state before entering the production process. The raw material area is usually required to maintain ISO 7 or higher cleanliness levels to prevent raw materials from being contaminated.

Mixed ingredients area

Drug formulation and mixing are carried out in this area, and strict cleanliness control is required. The mixed ingredients area usually needs to reach ISO 5 cleanliness to ensure the sterility and accuracy of the mixed ingredients process and reduce ingredient errors.

Production area

The area where the actual drug production is carried out must maintain high cleanliness and stable environmental conditions. The design of the production area takes into account the flow of personnel and materials, and usually requires ISO 5 or higher cleanliness standards to effectively prevent contamination by microorganisms and particles.

Packaging area

Responsible for the packaging of drugs to prevent contamination and damage. The packaging area should be maintained at ISO 7 or higher cleanliness to ensure sterility during the packaging process and protect the quality and safety of the finished product.

Inspection area

Quality inspection of finished products to ensure compliance with standards. The inspection area is usually designed as an independent space to avoid cross-contamination with other areas and maintain strict cleanliness requirements.

Storage area

Finished and semi-finished products are stored in suitable environmental conditions. The temperature and humidity in the storage area need to be strictly controlled, and the relative humidity is usually required to be between 30%-60% to prevent the deterioration of the drugs.

Auxiliary area

Including dressing rooms, toilets, etc., to ensure the cleanliness and hygiene of personnel. The dressing room needs to be designed as an air flow flushing area to ensure that everyone entering the clean room undergoes the necessary cleaning and changing procedures.

Environmental technical parameters of clean workshops in pharmaceutical factories

The environmental technical parameters of clean workshops in pharmaceutical factories are the key to ensuring production quality, mainly including

Cleanliness

According to the ISO 14644 standard, the cleanliness level of clean rooms is divided into multiple levels. In the pharmaceutical industry, clean rooms are usually required to reach ISO level 5 (no more than 3,520 particles above 0.5 microns per cubic meter) or higher to ensure the sterility of drugs.

Temperature

The temperature of the clean room is usually controlled between 20-25℃ to ensure the stability of drugs and materials and prevent temperature fluctuations from affecting the quality of drugs.

Humidity

Relative humidity is usually controlled between 30%-60%. Too high humidity may cause drugs to get damp, affecting their effectiveness and safety, while too low humidity may cause static electricity accumulation.

Pressure difference

A certain pressure difference must be maintained between the clean room and the external environment, usually 10-15Pa, to prevent external air from entering and polluting the environment in the clean room.

Air volume

According to the design requirements of the clean room, the air volume must reach more than 20 ventilations per hour to ensure the freshness and cleanliness of the air. At the same time, the programmed airflow design can effectively prevent airflow short circuits and dead corners.

Management system of clean workshops in pharmaceutical factories

The management system of clean workshops in pharmaceutical factories is to ensure the effective operation of clean rooms

The management system of clean workshops in pharmaceutical factories is the basis for ensuring the effective operation of clean rooms and maintaining environmental quality, which mainly includes the following aspects

Personnel management

All personnel entering the clean room must receive strict training, including aseptic operation, personal hygiene, and the correct way to wear protective clothing. Regular assessments are conducted to ensure that employees have mastered relevant knowledge and skills.

Before entering the clean room, you must go through the changing room to change and wear special clean clothes, gloves, masks, etc. Set up clear instructions for the changing process and equip necessary cleaning and disinfection facilities.

Environmental monitoring

Regularly monitor the concentration of microorganisms and particulate matter in the air of the clean room to ensure that it meets the prescribed cleanliness standards. Use special monitoring equipment to record data and analyze them.

Install an automatic temperature and humidity monitoring system to record and alarm in real time to ensure that the temperature and humidity remain within the set range and handle abnormal situations in a timely manner.

Cleaning and disinfection

Develop a detailed cleaning and disinfection plan, clarify the cleaning frequency and responsible person, and ensure regular cleaning of clean room surfaces, equipment and tools.

Select cleaning and disinfecting agents that meet GMP requirements to ensure that they will not affect the quality of drugs. Record the time, method and personnel of each cleaning and disinfection.

Material management

All raw materials must undergo strict quality inspection before entering the clean room to ensure that they meet the use standards. Set up a special raw material receiving area to avoid cross contamination with other areas.

Establish a material traceability system to record the source, use and inspection results of all raw materials for easy tracking and management.

Equipment management

Regularly clean and maintain the production equipment in the clean room to ensure its good operating condition. Maintenance records should record in detail the time, content and person responsible for each maintenance.

All production equipment must be verified to ensure that it operates normally in a clean room environment and meets relevant quality standards.

Accident handling

Develop an emergency plan to deal with emergencies caused by equipment failure, contamination, etc. Organize regular drills to ensure that employees can deal with various emergencies proficiently.

Establish an incident reporting system, any abnormal situation should be reported and recorded in a timely manner, analyze the cause and take improvement measures to avoid recurrence.

Actual Application Cases of Clean Rooms

In the biopharmaceutical industry, clean rooms are used to produce biological products such as vaccines and antibody drugs. For example, in a large biopharmaceutical company, the entire production process from receiving raw materials to packaging of final products is carried out in a clean room. Through strict environmental monitoring and aseptic operation, the factory has successfully achieved a product sterility rate of more than 99.99%.

Preparation Production

A pharmaceutical company implemented an ISO 5 Clean room on its oral solid preparation production line. Through an efficient air filtration system and airflow control, the cleanliness of the product during the production process is ensured. After the introduction of the clean room, the company's production efficiency increased by 20% and the failure rate dropped significantly.

Medical Devices

The production of medical devices also requires a clean room environment. For example, a medical device manufacturer set up a clean room in its product assembly workshop to prevent microbial contamination on the surface of the product. After implementation, the company's quality complaint rate after the product was launched on the market was significantly reduced, and customer satisfaction was improved.

Summary

Pharmaceutical factory clean rooms play a vital role in the pharmaceutical industry. The scientific nature of their design, management and operation directly affects the quality and safety of drugs. Faced with ever-changing market demands and regulatory requirements, pharmaceutical companies need to continuously innovate and optimize the management model of clean rooms to adapt to future development trends. Through the development of intelligent and green directions, clean rooms will provide strong guarantees for the sustainable development of the pharmaceutical industry.

Pharmaceutical clean room related reference standards

Here is a list of key reference standards related to pharmaceutical clean rooms:

• iso 14644-1: Specifies the classification of air cleanliness in clean rooms and controlled environments based on the concentration of airborne particles.

• iso 14644-2: Outlines the monitoring of airborne particulate cleanliness and provides guidelines for the testing and maintenance of clean room environments.

• ISO 14644-3: Details the methods for testing clean rooms and controlled environments, including the determination of airborne particle concentrations.

• ISO 14644-4: Focuses on the design, construction, and start-up of clean rooms and controlled environments.

• iso 14644-5: Addresses operational requirements, including the validation and monitoring of clean rooms and controlled environments.

• USP Chapter <797>: Provides guidelines for the compounding of sterile preparations, emphasizing the importance of clean room practices in pharmaceutical settings.

• USP Chapter <800>: Outlines standards for handling hazardous drugs, including requirements for clean rooms used in the preparation of such substances.

• FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing: Offers recommendations for the design and operation of clean rooms in the production of sterile drug products.

• EU Guidelines for Good Manufacturing Practices (GMP): Sets forth requirements for the manufacture and testing of medicinal products, including specifications for clean rooms.

• ISO 13485: Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.