What is a clean room? Clean room standard gmp, class 1 – class 100,000

Table of Contents

 
1. What is a Clean Room?

 

2. GMP Clean Room Standards

 

3. a) What is GMP Clean Room Standard?

 

4. b) Contents of GMP Clean Room Standards

* GMP requirements:

* Scope and subject of GMP

* Implementation steps

* Principle:

III. Class 1 Clean Room Standard 10 100 100 10,000 100,000 100,000

 
10. a) What is the Class 1 Clean Room Standard 10 10 100 1000 10,000 100,000?

 

11. b) Types of standard clean room class

 

12. b) Meaning of clean room class 1 10 100 100 10,000 100,000 100,000

 

13. Examples of 7 Clean Room Applications

 

14. What is a Clean Room?

– Clean room is a room (the air in the room, equipment surface, walls, ceilings, …) has a low level of pollution, the pollution is dust, bacteria, microorganisms, toxic gases, chemical vapors, etc. The level of cleanliness of a clean room depends on each area that has specific clean standards.
– From there, we design and execute the clean room to control the environment in the room to achieve the cleanliness required by each industry.

What is a clean room?

 
1. GMP Clean Room Standards

 

2. a) What is GMP Clean Room Standard?

– GMP clean room standard is a clean room designed to be constructed and operated according to GMP clean standards of the World Health Organization, and the clean room is required to meet the standards prescribed by the Ministry. Vietnamese health.

– GMP stands for Good Manufacturing Practices, translated as good manufacturing practice standards.

 
1. b) Content of GMP Clean Room Standards

* GMP requirements:

– Personnel: Standards of work position, qualifications, capabilities and fitness must be suitable. Procedures on health check and professional training plan.

– About equipment, location, design, factory installation

– About sanitation, factory environment

– Processing process

– Preserving and distributing products

As such, GMP makes the requirements from the input until the products reach the consumers, all must meet the standards of infrastructure, people, environment, processes, … for specific requirements. You are welcome to follow our next post.

GMP clean room standards

* Scope and subject of GMP control

– Device

– Factory

– Personnel
– Hygiene: Personal, environment, production

– Operations

– Materials

– Semi-finished products

– Product

– Recipe recipe

– Production conditions, …

– Product quality

– Supplier

– Handling of inappropriate products

– Customer complaints

– Documents and records

– … ..

* Steps to deploy

– Step 1: Prepare

+ Legal provisions

+ Standards on: materials, products, technical operations

+ Customer feedback

+ New scientific information

+ Experience of the business

+ Research results

– Step 2: Determining scope of GMP application

– Step 3: Prepare deployment plan

– Step 4: Doing procedures, regulations and standards for each stage

– Step 5: Human resource training

– Step 6: Apply and check

– Step 7: Adjust if not suitable

– Step 8: Put into official use

– Step 9: Monitoring, evaluation and improvement

* Principle:

– NT1: Customer-focused, customer-oriented

– NT2: Role of Leadership

– NT3: There was the participation of everyone

– NT4: Approach by process

– NT5: System method

– NT6: Continuous improvement

– NT7: Decision based on facts

– NT8: Cooperating with suppliers for mutual benefits

III. Class 1 Clean Room Standard 10 100 100 10,000 100,000 100,000

 
10. a) What is the Class 1 Clean Room Standard 10 100 100 10,000 100,000?

– Class 1 clean room standard 10 10 100 1000 10,000 100,000 is a clean room of graded cleanliness grade I – VI, based on dust content based on 1 cubic meter of air and depending on each criterion Standard: Federal Standard 209 (1963), Federal Standard 209 E (1992, ISO 14644-1, etc.) whose dust content will vary.

 
1. b) Types of standard clean room class

Class 1 clean room standard

Class 10 clean room standards

Class 100 clean room standard

Class 1000 clean room standards

Class 10,000 clean room standard

Class 100,000 clean room standards

 
10. b) Meaning of the clean room class 1 10 100 100 10,000 10,000 100,000

– Class 1 Clean Room is cleaner than Class 10 clean room

– Class 10 Clean Room is cleaner than Class 100 clean room

– Class 100 Clean Room is cleaner than Class 1000 clean room

– Class 1000 Clean Room is cleaner than Class 10,000 clean room

– Class 10,000 Clean Room is cleaner than Class 100,000 Clean Room

IV: Class cleanliness

Application of clean room levels:

 
1. a) Type 1 (Cleanroom Class 1)

– Room type of factories manufacturing integrated circuits with micro-size technology.

 
1. b) Type 10 (Cleanroom Class 10)

– Room type of semiconductor factories used to produce integrated circuits with width less than 2 ILm

 
1. c) Type 100 (Cleanroom Class 100)

– Room type requires no bacteria, dust for use in the production of sterile injections.

– Type of tissue transplant surgery room.

– Postoperative room type after bone tissue surgery.

 
1. d) Type 1000 (Cleanroom Class 1000)

– Type of room producing high quality optical equipment.

– Type of room manufacturing ultra-small size bearings.

 
1. e) Class 10,000 (Cleanroom Class 10,000)

– Assembly room of hydraulic, pneumatic equipment, auxiliary control valves, timing devices and high-quality actuators.

– Room type for use in the manufacture of sterile injections.

 
1. f) Type 100,000 (Cleanroom Class 100,000)

– Type of room used for optical work.

– Room type used to assemble electronic, hydraulic and pneumatic components.

– Types of rooms used to manufacture pharmaceuticals and foodstuffs

Class of cleanliness

 
1. Examples of 7 Clean Room Applications

– Clean room for cosmetic development and preservation

– Clean room of food preservation

– Clean room for electronics and IC production

– Clean room cultured microorganisms

– Clean medical room, surgery
– Clean room of pharmaceutical preservation
– Laboratory clean room, developing garment products

By now, do you understand what clean rooms are? GMP clean room standards , clean room standards class 100 class 1000 class 10000 include and their applications in life already.