What is a cleanroom? Cosmetic CleanRoom Standard
Cosmetics is a potential industry in Vietnam with a scale of about 2.3 billion USD per year. In order to produce cosmetic products that meet the standards for the market, cosmetic factories are daily using cleanroom systems as a mandatory and irreplaceable workspace.
So what is a cleanroom? What are the requirements and standards in the design and construction of cleanrooms? GMP Groups will help you respond through the article below.
1. What is a cleanroom?
Cosmetic cleanroom is a cleanroom system applied in the field of cosmetic manufacturing. These cleanrooms have their own levels and ensure certain standards of the manufacturing sector. Cleanrooms help the production process free from bacteria; This way, the cosmetics last longer.
2. Why do we need to build a clean room for a cosmetics factory?
Cosmetic products are very perishable and destroyed by bacteria. Because the ingredients are made, they are usually extracted from natural ingredients. The higher the demand for cosmetics, the more competitive for safety; The quality of cosmetics is increasing. That requirement requires the production of these products to be conducted in a well-controlled environment in terms of temperature, humidity, urinary, microbial limits, etc. That means building clean rooms to produce cosmetics.
The production of cosmetics in clean rooms helps businesses own quality products; Meet the strict requirements of the market. The product thus increases the competitiveness with domestic and foreign products.
Article 13, Chapter IV, circular regulating cosmetic management stipulates as follows:
“Organizations and individuals responsible for bringing cosmetic products to market must ensure that their products are not harmful to human health when used under normal or appropriate conditions guided, in accordance with the dosage form, the information stated on the label, instructions for use, special caution, as well as other information provided by the manufacturer or product owner.”
As fins, cleanrooms are a mandatory factor in the production of cosmetic products. Building a cleanroom is a need of any business that wants to pursue this field.
Cosmetic CleanRoom
3. Requirements and standards of cosmetic cleanroom
Since 2006, the cosmetics industry has relied on standards related to microbiological evaluation of its products. The design of a clean room has a direct impact on the safety of the environment or the operator.
It is impossible to produce high-quality, safe cosmetics without a clean area or clean room installed properly. If the cleanroom is not built properly, particles such as chemical vapors and contaminants can frequently pollute the sky, which can cause skin irritation, allergic reactions and disease. To prevent this, it is necessary to avoid installing insufficient ventilation systems, mis-designing auxiliary rooms and mis-planning the work area.
Applicable standards
Cosmetics in Vietnam are becoming more and more tightly controlled over time. Currently, establishments must meet certain production conditions in accordance with Decree 93/2016/ND-CP and Decree 155/2018/ND-CP. Especially to ensure the safety and quality of products as well as products allowed to trade not only domestic markets but also in asean associations, compliance with the principles and standards of ‘Good Practice guidelines for cosmetic production’ (cGMP-ASEAN) is a mandatory requirement.
Cleanliness in cosmetic production is not specifically mentioned in the guidance systems or principles, standards “good practice guidelines for cosmetic production” (cGMP-ASEAN) but the majority apply clean grade D (equivalent to ISO class 8 as classified in ISO 14644-1:2015) in pharmaceutical production into cosmetic production applications. In addition, depending on the quality control requirements of the manufacturer, higher clean levels can be applied.
Cleanroom application in cosmetic manufacturing will help control the quality and safety of cosmetics by:
Create clean, enclosed spaces. In which the number of urination and microbiganisms is controlled; avoid infecting the product beyond the permissible level.
– Control temperature and humidity within the required limits; in accordance with the quality characteristics of the product; at the same time limit the growth of microorganisms.
The pressure in the room is maintained and there are differences suitable for other production rooms. Therefore, minimize cross-contamination between different stages of production.
The frequency of air exchange in the room is maintained to an appropriate level. New airflow enters the room; pushing and taking over the old airflow causes the room to be constantly cleaned.
Principles
Besides controlling environmental factors in cleanrooms, cosmetic cleanrooms must be built in principle so that they themselves are not the infectious agents for the manufactured product. The principles are:
Design and layout
Clean rooms must be designed and arranged so that production is carried out in successive areas; according to a reasonable order corresponding to the order of production activities.
Working area
Ensure that the factory has sufficient area and equipment suitable to the cosmetic production line that the unit has registered, and must divide the area clearly. This minimizes the risk of confusion between products or its components; avoid cross-contamination and minimize the risk of omission; or misuse of any production step or inspection
Contact surface
The surface of the clean room where direct contact with the open product must be smooth, without cracks, open joints; must not be the source of accumulation and arising of urination, must allow cleaning of disinfection easily and effectively.
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. When conditions permit, maintenance must be carried out, access to these services from outside the production area.
Drainage
The drainage lines must be large enough, designed and equipped to avoid reflux. If possible, avoid open drainage. In case the opening is necessary, it is recommended to build a farm for easy cleaning and disinfection.
Ventilation
Must be well ventilated, have air control equipment (including air purifiers at sufficient levels to prevent contamination and cross contamination as well as temperature control, and humidity if necessary) suitable for the products being processed, in accordance with the operation performed and with the external environment.
4. GMP Groups – Designing and constructing a cleanroom of all cosmetics
With a team of experienced personnel in cosmetic, pharmaceutical and health food companies, understanding the nature of cosmetic cleanrooms, understanding production technology, GMP Groups ensures to provide customers with the most comprehensive services related to cosmetic cleanroom including:
– Consulting services, designing cleanrooms
– Cosmetic cleanroom construction service
– Cleanroom assessment and appraisal services
Why you should choose GMP Groups
Cosmetic cleanroom design team
– GMP Group has a team of experienced, enthusiastic and dedicated personnel who are pharmacists and engineers for many years operating in cosmetic, pharmaceutical and health food companies.
Understanding the production technology will therefore provide customers with the most effective and suitable design solutions
– Understand the requirements of cleanroom, clean supply, machinery and equipment- people in each stage of production from which will calculate for customers the requirements of area, air treatment system suitable, economical, most effective for customers.
– 3D design system for visual images combined with VR-360 technology helps customers experience the most practical factory and cleanroom spaces right from the design stage.
5. Conclude
With the desire to provide a comprehensive “ecosystem” of services related to the cosmetics sector; GMP Groups will be the perfect choice for any customer. Contact GMP Groups now to get the best services!
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
Hotline: 0945.255.457
Website: gmpgroups.com.vn
Email: info@gmpgroups.com.vn