KIS CORPORATION
 
KOREANENGLISH
 
 
 
 
 
CLEAN ROOM
HOME > CLEAN ROOM > CLEAN ROOM

본문

CLEAN ROOM CLEAN ROOM > CLEAN ROOM
Outline of a clean room

◆ Five principles

     Five rules of a clean room should be followed in order to use a clean room efficiently and keep it well.

 

      

VIDEO PDF DOWN
Outline of a clean room
◆ Type of clean room

     - ICR (INDUSTRAL CLEAN ROOM)
     - BCR (BIO LOGICAL CLEAN ROOM)
     - KGMP/BGMP (KOREA GOOD MANUFACTURING PRACTICES)
     - HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)
     - A sterilized room
     - A breeding room for sterilized animals

 

◆ The size of particles in the air

     There is a variety of dust floating in the air ranging from small dust perceivable to the naked eye, oil smoke and metallic powder to particles unidentifiable without optical aide.

     Their size varies from 0.01um to about 100um and there are 1,000,000 kinds of particles commonly present in the air.

     The size of particles one can identify with his naked eyes is over 10um. Those particles are so big that they should be eliminated by an air handling unit.

     The size of particles which are mostly controlled in a clean room are those of the submicron size (below 1um).
     FED in America regulates the size of purified particles using 0.5 um as a standard.

 

      

 

Clean room specification

◆ Outline of Fed. Std. 209E

 

 

◆ Key Revisions on Fed, std, 209E

Item Description
Unit Primarily the metric system is used and UK units are used in combination.
Class Expression The number of particles of 0.5㎛ or larger is defined with 10/㎥ and X is used for the mark of class. ‘M’ is added to clearly represent the mark of the metric system.
Class Classification Class M1 with higher level of cleanliness than that of 209D Class 1 and Class M7 with lower level of cleanliness than that of Class 100,000 were added.
Particle Instrumentation CNC can be used in instrumentation and the diameter of a particle instrumented can be 0.02㎛ or larger. In that case, Class U(X) is marked.U = Mark of Particle InstrumentationX = Maximum Particle Concentration (P/㎥)
Standard Measurement Particle It can be 0.1, 0.2, 0.3, 0.5 or 5 micron but other diameters may be used.
Sampling Other sampling flows may be used in instrumentation depending on the location of instrumentation but the particle concentration must be expressed as ‘number/unit volume.’If the number of sampling points is 10 or more, then a simple average may be used. If the level of cleanliness is higher than Class M2.5, a continuous sampling may be allowed for reducing the instrumentation time.
Annex Standards and terms related to 209D are deleted but the uniform velocity suctioning, super-fine particle concentration measurement and continuous sampling, for higher level of cleanliness than Class M2.5, are added.

 

 

◆ Air Current in Clean Room

     These represent the general rule about the selection of the air current velocity in a clean room.

     The air current velocity is specified as (1) average velocity (m/s or ft/m) or (2) the number of ventilation per hour (number / hour).

 

◆ Order of Plans


 

◆ Cautions on layout

Item Description
Entry&Exit - Minimize and separately consider Entry and Exit.
(Especially for the installation of air shower)
- Do not expose them directly to the air (Air Lock Room)
- Locate them downstream (Especially, Cross Floor).
Locker Room - Take as much as air for the locker room.
- Install a washstand and prepare drinks if many peoples gather.
- Install at least the double door between clean rooms.
(Install Air Shower Systems)
- Enable internal communications.
- Establish a rest room, if necessary.
Take In &Out - Use a pass box if applicable (parts).
- Attach a take-in hole. (Large Systems)
Indoor Arrangement - Simplify.
- Install the control office outdoor. Consider how to contact.
- Plan to expand.
- Minimize the movement.
- Consider the direction of fresh air current to arrange workplace.
- In works causing oscillation, use partitions, local exhaust and return duct.
Indoor Facilities - Minimize the exposure of wire and duct.
- Install the light system over the ceiling if applicable.
- Prepare for emergency, fire, blackout or poisonous gas.
- Install an inter-phone or telephone.
- Clean.
- Record particles concentration, temperature and humidity.

 

Clean room applications

◆ ICR(Industrial Clean Room)

 

An ultra-clean space provides a high quality. ICR is applied primarily to the semi-conduct industry represented by IC and VLSI and the scope of application has currently expanded to include new materials and fine chemicals.

 

For ICR, the investment in the clean room facility leads to increase in yield.

 

It means the investment in the clean room provides actual effectiveness. Experience data lets you know which cleanliness level is required for each product; The highest cleanliness level is applied to the most important process while an economic clean room should be prepared for other processes, if applicable. The following shows products and processes requiring an ICR and the air cleanliness level which is the most applied:


 

◆ BCR(Bio logical Clean Room)

 

Supporting the Development of Future Industries Such as Medicines and Food.BCR (Biological Clean Room) controlling microbes has been developed by the needs of GMP in manufacturing medicines and asepsis in an operating room of a hospital.

 

Also, a clean room similar to GMP is already applied to the food or cosmetic industry as well as the process manufacturing retort foods or long-term storing foods or processes charging drinks.

 

The facility experimenting with animals required for the manufacturing or development of medicines is subject to GLP which has a close relation with the technology for clean room.

 

 
 
 
KIS CORPORATION(Daeji Bldg 7Fl, Inkye-Dong) 446Beongil 20, Kyeongsu-Daero,
Paldal-Gu, Suwon-City, Kyeonggi-Do, South Korea
TEL : +82-31-222-2460 / FAX : +82-31-222-2461
COPYRIGHT 2016 ⓒ KIS CORPORATION. ALL RIGHTS RESERVED.
COMPANY - ABOUT US
- KIS HISTORY
PRODUCT - SOLID DOSE
- SOFT GELATIN
- PACKAGING
- LIQUID FILLING
- LAB EQUIPMENT
- TABLETS INSPECTION
- CLEAN ROOM
- CUSTOMER
CUSTOMER SERVICE - CUSTOMER SERVICE
- DOWNLOAD
CONTACT - CONTACT