What Are the Classifications of GMP Bio Pharma Clean Room
|10.5.2021||Posted by pharmasources under Advertising & Marketing|
The goal of biopharmaceutical companies requiring GMP is to ensure the establishment of a scientific and strict sterile drug production environment, process, operation and management system, to minimize all possible and potential biological activity, dust, and pyrogen pollution, and to produce high quality, hygienic and safe pharmaceutical products. What we call the bio pharma clean room-GMP clean plant engineering solution and pollution control technology is one of the main means to ensure the successful implementation of GMP.
Introduction to the classification of GMP bio pharma clean room
- Turbulent Flow
The air enters the GMP clean room from the air-conditioning box through the air duct and the air filter (HEPA) in the clean room, and returns to the GMP clean room by the partition wall panels on both sides of the GMP clean room or the raised floor. The air flow is in a non-linear motion and presents an irregular turbulence or vortex state. This type is suitable for GMP purification engineering grade 1,000-100,000.
Advantages: simple structure, low system construction cost, easy expansion of the clean room, in some special-purpose places, a dust-free workbench can be used together to improve the clean room level.
Disadvantages: The fine dust particles caused by turbulence float in the indoor space and are not easy to be discharged, and it is easy to pollute the process products. In addition, if the system is stopped and reactivated, it often takes a long time to achieve the required cleanliness.
The laminar air flow moves into a uniform straight line, and the air enters the room through a filter with a coverage rate of 100%, and returns to the air from the raised floor or partition walls on both sides. This type is suitable for use in environments where the GMP clean room level needs to be set higher. Generally, the clean room level is Class 1~100. Its types can be divided into two types:
(1) Horizontal laminar flow: The horizontal air is blown out from the filter in one direction, and the air is returned by the return air system on the opposite wall. The dust is discharged out of the clean room along the wind direction, and the pollution is generally serious on the downstream side.
Advantages: simple structure, stable in a short time after operation.
Disadvantages: The construction cost is higher than the turbulent flow type, and the indoor space is not easy to expand.
(2) Vertical laminar flow: The ceiling of the clean room is completely covered by ULPA filters, and the air is blown from top to bottom to achieve a higher degree of cleanliness. The dust generated during the manufacturing process or by the staff can be quickly discharged outdoors without Will affect other work areas.
Advantages: easy to manage, stable state can be reached within a short period of time from the start of operation, and it is not easy to be affected by the operation status or the operators.
Disadvantages: the construction cost is high, the flexible use of space is difficult, the ceiling hanger takes up a lot of space, and it is troublesome to repair and replace the filter.
- Mixed Type
The composite type is a combination or combination of turbulent flow and laminar flow, which can provide local ultra-clean air in the clean room.
(1) Clean Tunnel: 100% coverage of the process area or working area with HEPA or ULPA filters to increase the cleanliness level to above 10, which can save installation and operation costs. In this type, the work area of the operator must be isolated from product and machine maintenance to avoid affecting work and quality during machine maintenance. Most of the ULSI processes use this type. There are two other advantages of the clean tunnel: flexible expansion is easy; the maintenance of equipment can be easily performed in the maintenance area.
(2) Clean Tube: Surround and purify the automatic production line through which the product process passes, and raise the cleanliness level to above 100. Because the product is isolated from the operator and the dust-generating environment, a small amount of air can get a good cleanliness, which can save energy, and an automated production line that does not require manual labor is the most suitable for use. It is applicable to the pharmaceutical, food, and semiconductor industries.
Combined partial clean room (Clean Spot): The cleanliness level of the product process area in the turbulent flow clean room of the clean room level of 10,000 to 100,000 is increased to level 10 to 1,000 or higher for production purposes; clean workbenches, clean workshops, clean work sheds, and clean wind cabinets belong to this category.
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