GMP Production Workshop, buy LTPM Clean Room For Gmp pharmaceutical clean room turnkey project on China Suppliers Mobile

Product Details

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Product Description

GMP Medical Device Cleanroom Solutions

(1) It is crucial to maintain a contaminant-free clean environment when manufacturing medical devices such as biological implants.This starts with the clean room design and management systems. The clean room design prevents outside contamination, while regular maintenance and sanitation upkeep minimize the risk of contamination originating within the clean room itself.

(2) Implants that are non-sterile or are awaiting sterilization should be subject to purification and clean packaging processes. This will allow for uniformity and control over product quality. When constructing a GMP Medical Instrument Clean room, a location should be designated for the packaging process, and processes should be implemented to ensure that products avoid contamination risk at all times. For further reference, please see the YY0033-2000 Standards.

(3) Procedures must be developed to control environments in which there exists a contamination risk to products. This includes any time personnel makes contact with a product, including when products are moved from one location to another.

International Medical Instrument Cleanroom Standards

International Standard: ISO/DIS 14644
Chinese Standards: GB50073, GB50591, GB 50243
American Standards: GMP-97, GMP-98, FS209E

Considerations for GMP Medical Device Cleanrooms

(1) Carefully consider all construction materials to be used.
(2) Thoroughly examine your plans for design, installation, testing and maintenance
(3) Do not neglect to consider details--such as placement, size, and model--that concern the air purification system

Temperature and Relative Humidity
Except for certain special circumstances, the temperature of medical instrument cleanrooms should be calibrated between 18~28℃,with a relatively humidity of 45-65%. If you find that you are out of range for these standards, consider which instruments in the clean room may be acting as a heat source.

Air Velocity, Air Change Rate (ACR), and Static Pressure
The air change rate of a clean room is a function of the volume of air circulated into the cleanroom and the area of the clean room.Differences in static pressure result from differences in the the amount of air circulating through the air return vs. exhaust system vents. All of these variables can be adjusted through manipulation of fan speed and/or opening/closing the main vents. These can be adjusted for the entire system or for certain areas depending on the situation.

Keeping Out Dust, Bacteria, and Other Contaminants
Indications that your clean room may not be up to standard include falling out of standard in basic areas such as temperature,relative humidity and ACR. If these variables are out of standard, it is likely that your cleanroom is contaminated to a degree that is out of standard.

Proper calibration of the above conditions forms a sort of "microclimate" that is inhospitable to contaminants such as dust particles and bacteria. Meeting standards is a result of proper maintenance of the cleanroom. Regular, thorough testing is the only best practice, especially in a field where product contamination can lead to serious consequences. Besides designing your clean room, E-Clean can advise on how to implement management systems to maintain your clean room and minimize the risk for contamination.

Technical Parameters

Area	15㎡	30㎡	50㎡	100㎡
Material	Aluminum frame/Baking steel plaxe/lnsulaxing glass window			Aluminum frame/Baking sieel plate/lnsulating glass window
FFU class 1-100	12pcs	24pcs	48pcs	96pcs
FFU class-1K	3pcs	6pcs	9pcs	18pcs
FFU class-10K	2pcs	4pcs	6pcs	12pcs
Speed (m/s)	0.45m/s ±20%			0.45m/s ±20%
Temperature(optional)	18-28°C
Humidity(opiional)	50-70%			50-70%
Illumination	400-800LUX
Power	2.4-7kw	4.8-10kw	9.6-19kw	19.2-30kw

If there are other size requirements, it can be customized

Application Products

Pharmaceutical modular clean-room mainly engaged in offering full service for system clean room engineering, including product manufacturing, equipment transport, construction control, engineering acceptance test, etc. The engineering contains 4 sectors, decoration, HVAC, plumbing and electrical appliances, which includes the installation of process pipeline, water supply and drainage pipeline and purifying ventilation duct, power distribution of purification product and process equipment, security control, whole plant centralized control, etc, and which are widely used in food, electronics, pharmaceutical industry, and so on. Pharmaceutical modular clean-room has a first-class engineering design team to work from initial engineering design, further optimize the drawings according to practical construction experience, and even customize for clients. In the whole construction process, pharmaceutical modular clean-room strictly follows 4Q standard to monitor all construction nodes, applies 3 level control from plant construction to completion and uses advanced equipment to precisely test the later project. The company processes advanced ERP system and ensures the engineering, from quality to management, as high as international level.

Related Products

Company Introduction

Our Company

Zhejiang LeadTop Pharmaceutical Machinery Co.,ltd well known as LTPM China. Since year 1996, we are start manufacturing Oral Solid Dosage Pharmaceutical Machinery includes Mixing Machine, Drying Equipment, granulation line, IBC Bin and Bin Washing Machine. As year passed, LTPM China absorb advanced domestic and abroad technology, we export machinery to more than 30 countries all over the world.
LTPM China is considered one of the major Pharmaceutical Machinery Supplier and exporter in China mainland. Professional, Enthusiasm, Service and Team Work has been always our value to create for our Staff and customers. As year 2012 we position our value as “A Pharma Machinery Division, For A Better Life”, creating a Win-Win Platform for our clients and staff for a better life is our vision.

Our Machinery Manufacturing Workshop

Imported CNC Machining Centre makes all parts process accurate. Own R&D team with more than 20 years engineering expereince, can customize the equipment and packaging line to your satisfaction.

Professional Business Team

Warm, professional business team, careful response to your inquiry, timely response rate of more than 93%, higher than the average level of the industry.

Our Certificates

ISO, CE, SGS, BV Certified Company.

Packing & Shipping

All machine delivery with anti rust spray, film wrapping and Sea shipping affordable wooden box.

FAQ

Q: What price terms you offer?
A: We can offer FOB, FCA, CFR, CIF, EXW and other price terms based on your request.

Q: What payment terms you take?
A: TT, LC, other terms are also workable.

Q: Will you help with installation and stuff training?
A: Yes, we can send our engineers to your place to guide the installation and train your workers if you need, but the buyer should
bear our technician's round tickets, accomodation, food and subsidiary USD100/day.

Q: How can I visit your factory?
A: Our factory is located in Ruian city Zhejiang Province. Just let us know your scheduel in advance and we will arrange
everything for you!
Any other doubts about our machine, please feel easy to contact with us.