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In pharmaceutical cleanrooms, popular lines are characterized by 4 levels of cleanliness. This classification is based on the maximum number of sub-stools in the air. Join GMP Groups to learn about cleanroom lines and clean levels in pharmaceutical plants.

01

Clean levels of pharmaceutical cleanrooms

Depending on whether the product is manufactured sterile or not sterile, cleanrooms are divided into various levels of cleanliness. This is aimed at controlling environmental factors, especially urinary concentration and microbial limits. In areas with cleanroom applications, cleanroom levels are classified on the ISO 14644 platform.

From here, the Good Manufacturing Practice Guide (GMP) has classified cleanrooms in the pharmaceutical sector into 4 levels. This classification is based on the maximum number of sub-stools in the air.

For pharmaceuticals, clean levels are clearly classified in the good practice guidelines for the production (GMP) of sterile drugs including clean grade A, B, C, D. Depending on the product is a sterile or non-sterile requirement or non-sterile requirement stage that applies different levels of cleanliness.

02

Requirements for the construction of pharmaceutical cleanrooms and lines provided by GMP Groups

Yêu cầu xây dựng phòng sạch dược phẩm và các dây chuyền phòng sạch GMP Groups tư vấn thiết kế, thi công

Requirements for construction of pharmaceutical cleanrooms and GMP Groups cleanroom lines for design and construction consultancy

2.1. Requirements for the construction of a pharmaceutical clean room

In the production process, the environment is the factor that most affects the quality of pharmaceutical products. Depending on the different stages of production, the level of environmental control will vary. In which all stages where the environment is exposed to the product must be strictly controlled. In order to control the environment at the production stages exposed to the product, the environment must be in a safe and quality “clean room” space.

2.2. Pharmaceutical cleanroom line designed and constructed by GMP Groups 

GMP Groups advises on the design and construction of a number of pharmaceutical production lines to ensure GMP standards as follows:

– Solid drug production line: tablets, capsules, powder nudity 

– Liquid drug production line: solution, mixture, emulsion.

– Semi-solid drug production line: cream, grease, putr, synamed

*Sources of information based on the document: WHO technical report series, No. 961, 2011 – Good practice of sterile pharmaceutical production. 

Here’s an overview of GMP Groups’ pharmaceutical cleanroom service. For more information, please see more at: What is a pharmaceutical cleanroom? Standards of pharmaceutical cleanrooms

With the desire to bring a comprehensive service ecosystem related to the pharmaceutical sector, GMP Groups will be the perfect choice for any customer’s needs.

For more information on CONSULTING – DESIGN – CONSTRUCTION OF CLEANROOMS, please contact:

GMP Groups Joint Stock Company

Head office: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province

Hotline: 02203857968 ~ 0972345486

Website: gmpgroups.com.vn

Email: info@gmpgroups.com.vn

0972 345 486