Questions and answers with experts

Many companies ask us questions about clean room design and construction. We are very thankful for your attention. On behalf of TMV Company - We, the Customer Care department, please complete the following questionnaire and answer:

(For more information about our field, please send us an email- cskh@congnghelockhi.vn)

Question: What is GMP?

GMP (Good Manufacturing Practices) is a guide to good manufacturing practices, applied to food and pharmaceutical manufacturers and processors to control factors affecting the process of forming product quality from the design, construction and installation of workshops, equipment and processing tools; service conditions, processing preparation to the processing process; packaging, storage and human control activities during processing and processing. It covers every aspect of the manufacturing process and quality control.

Question: Which industries need to apply GMP standards?

In Vietnam, according to a decision of the Ministry of Health, GMP standards are mandatory standards applied to all areas of manufacturing and processing products that require high food hygiene and safety conditions such as:

Food.
Medicine.
Cosmetic.
Medical equipment.
Question: What are the benefits when businesses apply GMP standards in production?

When Vietnam joined the WTO, the competition for market share of products in the market was increasingly fierce. Enterprises investing in production lines that meet GMP - WHO standards will help pharmaceutical enterprises:

Demonstrate commitment in producing and trading safe food
Prepare the quality management system for HACCP certification
Increasing trust and reputation of enterprises with customers and consumers, creating favorable conditions for enterprises to export drugs to fastidious markets.
Increasing competitiveness with foreign products
Supporting when there is an evaluation of the competent authorities or related parties.
Question: Which agency has the right to receive cosmetic publication records?

Currently, there are about 3 agencies implementing cosmetic disclosure procedures as follows:

Drug Administration of Vietnam - Ministry of Health: The Drug Administration of Vietnam will carry out the procedures to announce cosmetics for imported cosmetic products.
Department of Health of a province: The Department of Health of a province / city will carry out the procedures for announcing cosmetics for domestically produced products.
For cosmetics traded within the industrial and commercial zone of Moc Bai border-gate economic zone, Tay Ninh province, to publicize at the Management Board of Moc Bai border-gate economic zone; cosmetic products within Lao Bao Special Economic - Commercial Area, Quang Tri province, shall be announced at Management Board of Economic Zone of Quang Tri Province.
Question: What is ISO 15378?

This is a quality management system applicable to the field of primary packaging production and secondary packaging applied to packaging used in the pharmaceutical, cosmetics, functional foods, and veterinary medicine industries.

Question: What is ISO 22000?

ISO 22000: 2018 (Food safety management systems - Requirements for any organization in the food chain / Requirements for organizations in the food chain) is designed on the basis of practice. following HACCP and GMP principles throughout the food chain. In particular, identification of critical processes, hazard analysis, identification of critical control points, etc., to establish appropriate control measures in combination with practice and compliance monitoring. are considered the key factors leading to success.

This set of standards sets out the requirements and guidelines that apply to organizations involved in the food chain from feed production, farming, processing, packaging, storage, transportation to supply. ration, .. irrespective of scale and type of food production. Thereby, helping organizations apply the establishment of an effective prevention system to prevent the occurrence of food safety risks.

This standard is applicable to all organizations wishing to implement a system to ensure safe product supply, regardless of size or participation in any aspect of the food chain.

Question: Is working in a clean room harmful?

According to records, in the 1860s, a professor at the University of Glasgow, Joshep Lister, set up a closed room system to limit dust and fight infections at the Royal Glasgow Clinic. Professor Lister's design was also the first clean room. Therefore, it can be said that clean room is used for the first time in the medical field. Thus, clean room was born to protect human health and currently there is no research document proving that working in clean room is harmful to human health.

Question: Do clean rooms need inspection after construction?

Have. Clean rooms are tested in 3 states:

Newly built clean room: That is, no machines and equipment in the room yet.
Verify that the room and equipment are installed but there are no employees yet.
Verify that the room and equipment are fully assembled, the equipment is working and the staff is working.
Measuring devices include: Dust meter, ATI filter leak, organic carbon total tester ...

Question: What is the role of Center 3 (QUATEST 3)?

QUATEST 3 provides calibration services, testing equipment and measuring instruments in the fields of mass, length, electricity, pressure, force, heat, physical chemistry, flow ... with systems and equipment. The equipment meets the requirements of linking standards to national and international standards, in accordance with standards of international measurement system.

Question: What is CO / CQ?

CO is a certificate of origin, English is Certificate of Origin.

CQ is a document that confirms that the goods are of a quality conforming to manufacturers' or international standards.

Question: Do clean rooms need maintenance?

Need clean room maintenance because:

To ensure the equipment in the room is always clean: A clean room is the space in which everything in it must be clean, especially the equipment in the room. Every device has a shelf life, timely maintenance is to replace expired equipment. Continued use of expired equipment will cause the clean room system to become contaminated.
To save money: Clean room after a period of pollution will become a normal room. Now if maintenance is no longer meaningful, forcing us to conduct a new clean room construction. Constructing a new room compared to maintenance of course is that maintenance will be more cost effective.
Increase the service life of the room: The maintenance of a clean room helps keep the internal standards at a reasonable level. When pollution does not come, the clean room time will be longer.

Question: What should employees working in a clean room follow?

Employees should note the following 2 things:

- When entering a clean room, wear protective clothing and specialized support equipment for the clean room, especially the electrostatic working environment.

- Must strictly obey the regulations on items as well as hygiene in a clean room: For example, do not bring food, personal watches ... When you want to bring something that you do not know if it is allowed or not to contact contact censorship.

Question: What are the causes of cross-contamination in a clean room?

10 Causes of cross-contamination in clean rooms:

Cross-contamination is the physical movement or movement of harmful bacteria from a person, an object, from a contaminated place, ... to a person, an object, a clean place.

1. The first reason: Installation is not complete.

A clean room is usually a closed room, in which the amount of dust in the air is kept to a minimum, to avoid contaminating the research, manufacturing and production processes. Space in a clean room is an enclosed space that is controlled in all aspects such as temperature, humidity, pressure, cleanliness, cross-contamination. Incomplete installation means that one of the above factors has not been controlled or the installation has encountered an undetected problem and is also the cause of cross-contamination during a clean room. when put into use.

2. The second cause: Non-compliance with hygiene procedures.

Regulations on hygiene in clean rooms are very strict because the failure to keep hygiene in the room is where the germs and bacteria proliferate, causing imbalance and cross contamination in the clean room. Cleaning of clean rooms must be done regularly to ensure cleanliness during the production of products.

3. Third cause: Do not install a waste treatment system.

When counselors for their customers must advise the installation of waste treatment systems in areas outside the clean room. The fact that you do not advise to install a clean room waste treatment system will increase the amount of waste that is not fully treated, causing microbiological and parasitic drives to contaminate the clean room.

4. The fourth reason: Filter levels do not match.

The filter level is the decision of the class of a clean room such as class 100, class 1000, class 10000 ... in the clean room. Filter levels that are not suitable for room equipment are also the cause of cross-cleaning in clean rooms.

5. The fifth reason: No appraisal of cleaning procedures.

Mandatory requirement is a cleaning procedure in a clean room. However, that process is suitable for your clean room is not a certainty. Therefore, it is necessary to appraise the cleaning procedure. You must find the cleaning procedure that best fits the clean room of your factory or company to avoid cross-contamination during use.

6. The sixth reason: Incorrect area layout.

The layout of the room in a clean room is extremely important and calculated, consistent right from the initial design. The automatic change of the location of the manufacturing machine in a clean room must be calculated and consulted by an expert to ensure the prevention of cross-contamination in a clean room.

7. Seventh cause: Improper classification of clean areas.

Usually all areas in a room are clean according to a single Class standard.

However, there are some special industries such as pharmaceutical production, the testing area is often the area with higher cleanliness requirements than other areas in the clean room. So when the contractor does not pay attention to this problem, it will lead to cross-contamination.

8. The eighth reason: Install an air conditioning system for the entire area inside and outside the clean room.

To save a lot of companies have installed an air conditioning system for the entire area in clean rooms and outside clean rooms. It is completely wrong, when installing a clean room, it is required to have a separate air conditioning system and not with any other system, the guarantee of cleanliness is stable.

9. Ninth cause: The material path is wrong compared to the regulations.

How to put production materials into clean rooms has been carefully calculated. However, when operating in order to save time in the production process, the material path may be changed by employees, resulting in cross-contamination and failure to ensure cleanliness in a clean room. Therefore, companies must have instructions and requirements to force their employees to properly enforce to ensure cleanliness in the room.

10. The tenth cause: Employees have not walked the right way for themselves.

Like the path of production materials, the path of people in a clean room will also be carefully calculated. Employees who do not walk in the right direction for them will break the cleanliness of the clean room and also cause cross-contamination. Therefore, there must be clear regulations for employees on the right path for them.

The problem of cross-contamination is quite complicated so when the contractor needs detailed and clear advice to the investor.

(Mind To - Reach - ... To - Anonymous)

Question: What causes pollution in a clean room?

1. People

People are the main reason that can cause pollution in clean rooms because people are the main factor working in clean rooms, operating in clean rooms the most. Usually in a clean room, there will be a lot of mandatory regulations for workers when operating in the clean room area to ensure cleanliness and avoid pollution during work. Clothes in a clean room also have quite strict rules about wearing and cleaning it in a clean room.

2. Equipment for working

The second reason not to mention the service equipment in the clean room. In addition to the human factor, the equipment working in a clean room also needs specific regulations such as location, how to clean after using ... To ensure that there is no environment for bacteria to have nesting and reproducing.

3. Installation equipment for clean rooms.

Equipment installed for clean rooms such as passbox, HEPA filter, air conditioner, air shower are devices designed and born to control cleanliness in clean rooms. However, it is a device that needs a separate warranty and maintenance so that they can work well and properly use it. Normally, after a period of time the equipment is often dirty, which reduces the control and cleaning function, resulting in low efficiency. Please regularly maintain, maintain and clean the equipment in the clean room so that your clean room always ensures your cleanliness.

Question: What is pressure?

In physics, pressure (commonly abbreviated as p or P) is a physical quantity, defined as the force per unit area of ​​action perpendicular to the surface of the object. In the SI system, the unit of pressure in Newton per square meter (N / m2), it is called Pascal (Pa) named after the 17th century French mathematician and physicist Blaise Pascal. The pressure of 1 Pa is very small, it is roughly equal to the pressure of a dollar acting on the table. Usually the pressure is measured with the ratio starting with 1kPa = 1000Pa.

Question: Should a mobile disinfection chamber be used during Covi-19 season?

The Ministry of Health said it had received research proposals from its subsidiaries. However, the proposal has not been approved by the Ministry of Science Council due to insufficient documentation and need to be assessed for its effectiveness and safety against viruses. Therefore, during the Ministry of Health's consideration and evaluation, organizations and individuals should not use it to ensure safety.

The Ministry of Health also said that the whole body's disinfection chamber is currently proposed in terms of structure usually consisting of one chamber (active spray of chlorine solution) or two chambers in succession.

Accordingly, chamber 1 sprayed ozone gas with the concentration of 0.12ppm for 30 seconds, then chamber 2 sprayed (mist particles of 5 sươngm) electrolytic water (anolyte solution or Javen water, disinfected by active chlorine) in 30 seconds.

However, ozone is harmful to human health, especially to the elderly, children and people with respiratory diseases. As recommended by the National Institute of Occupational Safety and Health, ozone levels in the air should not exceed 0.10 ppm at any time. There is no recommendation to use ozone to disinfect clothes, human skin in normal conditions. There have been no published studies showing the active chlorine spray solution disinfects clothes and human skin within 30 seconds. Active chlorine spray form penetrates into the airways and lungs which are harmful to humans when inhaled.

"The World Health Organization (WHO) does not recommend the application of misting methods in surface disinfection," the Ministry of Health said.

According to the Ministry of Health, the people now take simple, easy, but effective preventive measures such as: don't go out if not necessary, if you have to go out, keep a distance from people less At least 2 meters and wear a mask, regularly wash your hands with clean water and soap or hand sanitizer with an alcohol content of at least 60% ... (https://www.24h.com.vn/tin- tuc-in-today / bo-y-te-no-gi-back-buong-khu-khu-khu-khu-khu-phong-ap-luc-am-chong-covid-19-c46a1135487.html)

Question: Is "anti-epidemic hat" resistant to translation?

Doctor Chau Thi Manh Thu - Department of Otolaryngology - Hospital of Thong Nhat Hospital - added that the use of these shielded hats has not been recommended by the Ministry of Health. If overused they will create a sense of virtual security, ignoring the basic precautions.

Therefore, Dr. Thu recommends that people follow health care recommended by the Ministry of Health to wash their hands regularly with soap and a proper mask to ensure safety.