What is a pharmaceutical cleanroom? Standards of pharmaceutical cleanrooms
Pharmaceutical cleanrooms are a must for pharmaceutical factories. In order for the factory to be licensed to operate production, clean rooms must meet many strict standards and requirements. So what is a pharmaceutical cleanroom? What standards do pharmaceutical factories meet when building clean rooms? GMP Groups will answer the above questions through the following article.
- 1 What is a pharmaceutical cleanroom?
- 2 Why do pharmaceutical companies need clean rooms?
- 3 Requirements and standards of pharmaceutical cleanrooms
- 4 GMP Groups – Unit of design and construction of all-inclusive pharmaceutical cleanroom
What is a pharmaceutical cleanroom?
Clean rooms are specially designed workspaces. There, parameters such as urinary concentration, temperature, humidity, pressure, microbial limits,… Controlled and restricted.
Clean rooms are often applied to areas that require strict safety and quality requirements. Those areas include surgical, pasteurization, cosmetics manufacturing, pharmaceuticals, electronic components.
Pharmaceutical cleanroom is a cleanroom system applied in the field of pharmaceutical production. Thanks to cleanrooms, medicines and medical equipment are produced in sterile environments, according to the best production and storage standards. From there, the undesirable effects in the process of using pharmaceuticals are minimized.
Why do pharmaceutical companies need clean rooms?
Pharmaceuticals are products that directly impact human health. They need to be strictly controlled for safety and quality requirements right from the stage of production.
In the production process, the environment is the factor that most affects the quality of the product. Therefore, the environmental stages of open contact with the product must be strictly controlled. In the pharmaceutical cleanroom, the clean area is maintained at appropriate clean standards, the air is filtered through the filter membrane with appropriate filtration performance, people and/or machinery equipment, raw materials are passed through the airlocks. The above factors have ensured that the pharmaceutical production process reaches sterile levels.
As such, cleanrooms are a mandatory and indispensable factor in pharmaceutical factories. When appraising, cleanrooms also play a decisive role in the pharmaceutical plant meeting GMP standards.
Requirements and standards of pharmaceutical cleanrooms
In order to be granted a production eligibility license, pharmaceutical factories need to meet the strict criteria of facilities, personnel and quality management system of cleanrooms.
Depending on the product produced, the cleanroom is 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. Concrete:
Principles of design and construction of pharmaceutical cleanrooms
In order to control environmental factors well, cleanrooms must adhere to the following principles:
Design and layout
Clean rooms must be designed and arranged so that production is carried out in successive areas in a reasonable order corresponding to the order of production activities.
During the production process, there must be enough area to arrange machinery and materials in order and reasonable. It is necessary to minimize the risk of confusion between products or components of the product. Avoid cross-contamination, minimize the risk of omissions or misalisnment of any production steps, inspections.
The surface of the clean room where direct contact with the open product must be smooth, without cracks, open joints. The surface must not be the source of accumulation and feces. They must allow for easy and effective cleaning of disinfection.
Difficult area to clean
Ducts, light troughs, ventilation points and other services must be designed and installed so as to avoid creating difficult niches for cleaning. At the same time, it is required to carry out maintenance and access to these services from outside the production area.
The drainage lines must be large enough, designed and equipped to avoid reflux. If possible, avoid open drainage. In case the open exit is necessary, it is recommended to build a farm for easy cleaning and disinfection.
Cleanrooms must be well ventilated, have air control equipment (including air filtration equipment at sufficient levels to prevent contamination and cross-contamination as well as temperature control, and humidity if necessary) in accordance with the products being processed, in accordance with the operation performed and with the external environment.
GMP Groups – Unit of design and construction of all-inclusive pharmaceutical cleanroom
There are many units on the market, but most units are only capable of providing a few of the stages of cleanroom construction, causing businesses to incur more time and costs. GMP Groups brings the difference as a rare unit capable of providing comprehensive and comprehensive solutions in the field of designing and constructing pharmaceutical cleanrooms.
GMP Groups Services
Proud to be the unit designing and constructing the all-inclusive pharmaceutical cleanroom, the set of “turnkey” solutions that GMP Groups offers includes:
The reason to choose GMP Groups is the unit designing and constructing a clean room for pharmaceuticals
GMP Groups is trusted by investors as a pharmaceutical cleanroom service provider because of the following strengths:
3D design system and VR-360 technology is a technological breakthrough of GMP Groups. This technology allows customers to experience the most vivid factory space and clean room right from the design stage.
– Experienced, enthusiastic, dedicated staff. GMP Groups’ employees are pharmacists and engineers who have been operating for 5-15 years in pharmaceutical companies.
GMP Groups understands the production technology of each dosage form. From there, we will provide our customers with the most effective and suitable design solution.
– We understand the requirements of cleanroom, clean supply, machinery and equipment- people in each stage of production. We can calculate for customers the requirements of area, air treatment system suitable, economical, most efficient.
See more of our pharmaceutical cleanroom projects at: Pharmaceutical sector project
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 CLEANROOM, please contact:
GMP Groups Joint Stock Company
Head office: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province