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ISO 7 GMP Pharmaceutical Clean Room

Short Description:

With over 20 years’ experience in clean room industry, we have comppleted plenty of overseas cases around the world. We can provide one-stop service from initial planning to final operation for your pharmaceutical clean room according to international standard ISO 14644, GMP, FDA, WHO, etc. Let’s go through your clean room layout at the beginning before further discussion!


Product Detail

Product Tags

Product Description

Pharmaceutical clean room is mainly used in ointment, solid, syrup, infusion set, etc. GMP and ISO 14644 standard are usually considered in this field. The target is to build scientific and strict sterile clean room environment, process, operation and management system and extremely eliminate all possible and potential biological activity, dust particle and cross contamination in order to manufacture high-quality and hygienic drug product. Should focus on the key point of environmental control and use newly energy-saving technology as preferred option. When it is finally verified and qualified, must be approved by local Food and Drug Administration first before putting into production. GMP pharmaceutical clean room engineering solutions and pollution control technology are one of the main means to ensure the successful implementation of GMP. As a professional clean room turnkey solution provider, we can provide GMP one-stop service from initial planning to final operation like personnel flow and material flow solutions, clean room structure system, clean room HVAC system, clean room electrical system, clean room monitoring system, process pipeline system, and other overall installation supporting services, etc. We can provide environmental solutions that comply with GMP, Fed 209D, ISO14644 and EN1822 international standards, and apply energy-saving technology.

Technical Data Sheet

 

 

ISO Class

Max Particle/m3

Floating Bacteria cfu/m3

Depositing Bacteria (ø900mm)cfu/4h

Surface Microorganism

Static State

Dynamic State

Touch(ø55mm)

cfu/dish

5 Finger Gloves cfu/gloves

≥0.5 µm

≥5.0 µm

≥0.5 µm

≥5.0 µm

ISO 5

3520

20

3520

20

<1

<1

<1

<1

ISO 6

3520

29

352000

2900

10

5

5

5

ISO 7

352000

2900

3520000

29000

100

50

25

/

ISO 8

3520000

29000

/

/

200

100

50

/

Product Details

clean room system

Structure Part
•Clean room wall and ceiling panel
•Clean room door and window
•Clean rom profile and hanger
•Epoxy floor

clean room hvac

HVAC Part
•Air handling unit
•Supply air inlet and and return air outlet
•Air duct
•Insulation material

clean room facility

Electrical Part 
•Clean Room Light
•Switch and socket
•Wires and cable
•Power distribution box

clean room monitoring

Control Part
•Air cleanliness
•Temperature and relative humidity
•Air flow
•Differential pressure

Turnkey Solutions

clean room planning

Planning&Design
We can provide professional advice
and best engineering solution.

clean room material

Production&Delivery
We can provide top-quality product
and do full inspection before delivery.

clean room construction

Installation&Commissioning
We can provide overseas teams
to make sure successful operation.

clean room commissioning

Validation&Training
We can provide testing instruments to
achieve validated standard.

About Us

clean room solutions

•Over 20 years’ experience, integrated with R&D, design, manufacturing and sales;

•Accumulated over 200 clients in over 60 countries;

•Authorized by ISO 9001 and ISO 14001 management system.

clean room facility

•Clean room project turnkey solution provider;

•One-stop service from initial design to final operation;

•6 main fields such as pharmaceutical, laboratory, electronic, hospital, food, medical device, etc.

clean room factory

•Clean room product manufacturer and supplier;

•Obtained plenty of patents and CE and CQC certificates;

•8 main products such as clean room panel, clean room door, hepa filter, FFU, pass box, air shower, clean bench, weighing booth, etc.

Production Facility

clean room manufacturer
clean room fan
hepa ffu
hepa filter manufacturer
clean room factory
ffu fan filter unit
8
4
2

Product Display

rock wool panel
clean room door
fan filter unit
pass box
laminar flow cabinet
dust collector
hepa filter
hepa box
weighing booth

FAQ

Q: How long will your clean room project take?

A: It is usually half year from initial design to successful operation, etc. It also depends on project area, work scope, etc.

Q: What's included in your clean room design drawings?

A: We usually divide our design drawings into 4 part such as structure part, HVAC part, electrical part and control part.

Q: Can you arrange Chinese labors to overseas site to do clean room construction?

A: Yes, we will arrange it and we will try our best to pass VISA application.

Q: How long can your clean room material and equipment be ready?

A: It's usually 1 month and it would be 45 days if AHU is purchased in this clean room project.


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