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How to Control Cross Contamination in Pharma Clean Rooms

With the implementation of the new version of GMP, China has put forward higher requirements for the quality of pharmaceuticals. GMP is a national mandatory policy for pharmaceutical companies, and companies that fail to meet the requirements within the time limit will stop production. It is understood that whether the drug quality meets the standard is a very complicated process, and the cleanliness is one of the important consideration factors to measure whether a production workshop meets the basic requirements.

  1. What is cross-contamination in the pharma clean room

According to relevant staff, cross-contamination must be avoided during the operation of the pharma clean room to avoid huge losses. The so-called cross-contamination refers to the mixing of different components in activities such as personnel commuting, material transportation, tool transportation, air flow, equipment cleaning and disinfection, and post clearance to cause pollution; or the pressure difference causes air in low cleanliness areas to flow into cleanliness High areas, which are fatal for pharmaceutical clean rooms.

  1. Reasons for the unqualified cleanliness in the pharma clean room

According to the inspections of relevant agencies, there are many reasons for the unqualified cleanliness, such as unreasonable engineering design, replacing high-end products with low-grade products, poor sealing of air supply ducts or filters, design of return air ducts or return air outlets. In addition, the debugging is not good, the self-cleaning time of the clean air-conditioning system is not enough during the test, the clean air-conditioning system is not cleaned, and the clean plant is not cleaned thoroughly.

  1. How to prevent cross infection in the pharma clean room

The core content of GMP certification is the overall management and control of the quality of pharmaceutical production, and the control of the cleanliness of the pharma clean room, which has a direct impact on the quality of pharmaceutical production. So how to prevent cross infection in the pharma clean room? The “Code for Design of Clean Workshops” implemented in 2013 clearly stated that the clean workshops should “the process layout should be reasonable and compact. Only necessary process equipment and processes and studios with air purification requirements should be arranged in the pharma clean room or clean area.”

To improve the cleanliness of the pharma clean room, a reasonable layout is first required. For the indoor layout, it is necessary to carry out the layout according to a reasonable technological process to avoid going back and forth. A reasonable layout is based on the consideration of equipment size and process operation requirements. The production area and storage area should have a space suitable for the scale of production for the placement of equipment and materials for easy operation and maintenance.

It is understood that the height of the general pharma clean room is controlled at 2.60 meters, and the height of individual higher equipment can be increased locally, and it is not appropriate to increase the height of the clean area in an all-round way. There should be an intermediate station for materials inside the workshop, with an area sufficient to store materials, intermediate products, products to be inspected and finished products, and easy to clearly partition, so as to minimize errors and cross-contamination.

Secondly, the level of equipment needs to be improved. It is understood that the material, processing accuracy, airtightness and management system of the equipment are all related to cross-contamination. Therefore, in addition to reasonable layout, improving the automation level of equipment and forming a linked production line to reduce operators and reduce the frequency of personnel activities is a necessary measure to prevent cross-contamination.

In addition, companies also need to set up air-conditioning purification systems for pharma clean rooms according to different cleanliness levels, such as highly toxic microorganisms, anti-tumor drugs and other drugs with high cleanliness requirements. The exhaust vents need to be installed with high-efficiency filters to achieve the highest cleanliness. In addition, a separate local exhaust system should be provided for the toxic, flammable and explosive gas of the discharged medium. The supply air, return air and exhaust air need to have a start-up interlocking device, and the air outlet must have an anti-inflow device.

Medicine is a special commodity. The quality of medicine is directly related to the health of the people. It is the duty of every enterprise to improve the quality of pharmaceuticals. Among them, maintaining the cleanliness of pharmaceutical cleanrooms is an important aspect of pharmaceutical quality, and enterprises need to increase their efforts to improve the quality of pharmaceuticals. The cleanliness of the pharma clean room. In addition to the above methods, companies also need to set up special passages for people and logistics, and take measures to seal pipelines. The clean workshop is one of the largest part of the capital investment in the comprehensive management and control of drug production quality. After the completion of the clean workshop, whether it can achieve the design goals and meet the requirements of GMP, it will eventually be confirmed through testing. Therefore, companies need to control every detail when constructing clean plants to ensure that the clean plants are qualified and meet the pharmaceutical production standards.

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