GMP Clean Room and GMP Standards

GMP Clean Room and GMP Standards

GMP Introduction

GMP is the abbreviation of Good Manufacture Practice, is the reasonableness of the production process, the applicability of the production equipment, accuracy and normative of the production operations made ​​mandatory requirements. The latest edition of " Good Manufacturing Practice ( revised 2010 ) ‘’ was October 19, 2010 defined by the Health Ministry for consideration by hereby release , since March 1, 2011 came into effect.
GMP is the basic criteria for pharmaceutical production and quality management, is the key processes affected product quality in production of pharmaceutical preparations entire process and the manufacture of APIs. Vigorously promote drug GMP, in order to avoid possible contamination of pharmaceutical production processes and cross-contamination to reduce all kinds of errors occur, is an important measure to improve the quality of medicines .
At present, drugs produced in China sales in worldwide required manufacturers not only to comply with the of China 's version of 2010 GMP norms, but also in line with international EU / GMP standards, FDA-c GMP requirements.
GMP did not list the biological clean room design, construction, testing and other requirements. The details should refer to the relevant GMP implementation guide, drug GMP certification examination assessment standards, FED209E, ISO14644, ISO14698, IEST, international GB / T, EN1822 standards
Clean room and contamination control technology is one of the main means to ensure that GMP successful implementation.

Biological Clean Room Standards

Air Clean Class Level
Bio- clean room air clean area is divided into four areas:
Class A - high-risk operation area, which directly affects the operation area. Like sterilization tunnel oven, aseptic filling, bottle opening, autoclave cooling zones required 100 clean class laminar flow. Direct impact on the quality of products, called Class A.
Class B - indirect effects of the sterile operating area directly surrounding the class A area, like aseptic filling room, autoclave cooling room.
Class C and D - into the transition clean zone of the sterile production area. Preparation Room, changing rooms and a buffer room.

GMP RSP Grading in Different Standards Roughly Contrast

Prepared By: Vanessa Wang from Web:


What is the difference between clean booth and modular clean room?

What is the difference between clean booth and modular clean room?

1. Clean booth
Clean booth, also known as clean shed / softwall clean room / ISO5 laminar flow clean booth /1000class ISO6 clean booth/ 10,000 modular clean room, transparent plastic sheeting to prevent static electricity in the chaotic stream of clean room space surrounded by a small space, using HEPA or ULPA and independence of air conditioning units and become a more senior of the clean room, the level of 100 to 10,000 , the interior space of about 2.0 meters in height, covering an area of ​​about 50m2 or less, four pillars can be installed wheels, for flexibility in the use, supporting Air shower use.

2. Clean booth material :
Framework clean booth generally three types: stainless steel square pass, iron square pass, aluminum.
Clean the top shelf material generally three types: stainless steel, cold rolled steel spray , anti -static power grid around the curtain , (anti-static ) acrylic sheet .
Clean air section , the general choice FFU laminar flow hood (FFU laminar flow air supply unit )
Clean booth envelope materials generally include : anti-static curtain around , (anti-static ) acrylic sheet.

3. clean booth purification level selection:
More customers will choose one thousand clean booth , or ten thousand clean booth , a small number of customers will choose one hundred or ten thousand . In short, clean booth -level choices that customers need cleanliness may be, but relatively clean booth closed , such as when selecting clean booth level is relatively low , they tend to bring some side effects : insufficient cooling capacity , will shed staff in a clean I feel more hot, so the actual and the customer communication process , you need to pay attention to this point.

4. The cost of the clean and dust-free workshop shed comparison:
Generally speaking , most customers will clean booth built in the clean room , but some customers do not want to build a separate clean room, clean booth in the air conditioning system and does not consider air shower , pass the case of window cleaning equipment , etc. cost clean booth is about 40% to 60% clean room cost , depending on the customer 's choice of clean booth material , as well as the size of the clean booth . The greater the need to clean the area , the cost of clean and dust-free workshop shed will be smaller compared to the difference.

5. clean booth advantages:
A. Construction of fast, easy installation
B. low cost , easy maintenance
C. easy to control , FFU each comes with fan;

6. clean booth drawbacks:
A. because of the extensive use of FFU fan filter unit , so clean booth noise may be relatively large ;
B. FFU comes with fan , fan and more, to maintain high frequencies ;
C. due to reasons of space air , clean shed will often feel hot ;


Biological Safety Cabinet Specifications of Anlaitech Brand is On sales! Now!!

Biological Safety Cabinet Specifications of Anlaitech Brand

On sales!! Cost only 4876USD PER UNIT EX FACTORY

Model:  BSC-1500II-B2-X
Working area: 1300*600*660mm(W*D*H)
External size: 1500*850*2200mm(W*D*H)
Material: epoxy powder coated cold rolled steel for body
work zone made of 304 stainless steel
Safety height:</=200mm
Max opening: 400mm
Inflow velocity: 0.53m/s
Down flow velocity: 0.33m/s
Filter: 2set HEPA filter (99.999%@0.3um)
Front window: two layer toughened glasses (T=5mm)
UV lamp: 30W*1
Fluorescent lamp: 28W*1
Water and Gas tap: 1pc of each
Waterproof socket: 2pc
VFD display, microprocessor control system
Airflow:100% air exhaust
Cast wheel: directional wheels
Power: 1500W, 220V 50hz, 1phase

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Sales Consultant, Vanessa ( email:

Matched Medical Standard ISO