Purification project

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Pharmaceutical purification project - Baian Pharmaceutical
Pharmaceutical purification project - Baian Pharmaceutical

Pharmaceutical purification project - Baian Pharmaceutical

Project Name：Shanghai Baian Pharmaceutical Co. Project content：100,000 class purification project Industry Category：Pharmaceutical purification project

Category:

Medical Biology

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Project Description

Baian PharmaceuticalClass 10,000 cleanWorkshopDecoration

 

Project Name：Shanghai Baian Pharmaceutical Co.

Project content：100,000 class purification project

Industry Category：Pharmaceutical purification project

 

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■Introduction of Baian Pharmaceutical

      Shanghai Baian Pharmaceutical Co., Ltd. office is located in China's big city, the magic city of Shanghai, Shanghai Shanghai Jinshan District, Fengjing Town, Fengguan Road No. 285, was established on August 23, 2010, in the company's development and growth of 9 years, we always provide customers with good products and technical support, sound after-sales service, our company mainly engaged in ointment (with hormones), cream (with hormones), gel (with radicals), nasal spray (hormones) production.

 

     The 100,000-grade clean workshop and 10,000-grade clean workshop renovation projects constructed by Shanghai LJ have successfully passed the third-party authoritative clean room inspection and met the requirements of GMP workshop certification.

 

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■ Design basis

Drug production quality management standard (2010 year revised)

Drug production quality management standard (2010 revised) (Ministry of Health Order No. 79 No.) Appendix I

■ Key Notes：
1, personnel purification
1-1, personnel purification: Biomedical clean room (area) of personnel purification procedures should be arranged according to the following chart

 
1-2, the entrance of the pharmaceutical clean area should be set up airlock room; airlock room access door should be set up interlock device.
1-3, air cleanliness level of the same sterile clean room and non-sterile clean its personnel purification with room should be set up separately.

 

2、Material purification
2-1, pharmaceutical clean room of raw and auxiliary materials, packaging materials entrance and exit, should be set up with material purification room.
2-2、In addition to meeting the above requirements, the raw and auxiliary materials and packages entering the aseptic clean room should also be set up at the entrance and exit of the material sterilization room and sterilization facilities.
2-3, material cleaning room or sterilization room and pharmaceutical clean room, should be set up between the airlock room or transfer cabinet.
3, 100,000 level and above area work clothes should be washed, dried and overall in the clean room, and sterilized when necessary as required.

 

3.Pharmaceutical clean room air cleanliness level
Pharmaceutical clean room (area) air cleanliness level：

Air Cleanliness
Grade

Maximum allowable number of suspended particles (pcs/㎥)

Maximum allowable number of microorganisms

≥0.5um

≥5um

Planktonic bacteria (cfu/ ㎥)

Settling bacteria (cfu/dish)

100

3500

0

5

1

10000

350000

2000

100

3

100000

3500000

20000

500

10

300000

10500000

60000

—

15

Related Cases

Choose us  Five advantages

line

Focus on food and drug, electronic industry clean room one-stop solution  18years since the establishment of a professional safety management system

18 years industry experience

1、18 years industry experience

◆ 18 years of precipitation

◆ 200 successful cases

◆ Repeat customers and word-of-mouth customers account for a high percentage

◆ Increasing number of well-known corporate clients

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Construction Level 2 Qualified Enterprise

2、Construction Level 2 Qualified Enterprise

◆ Decoration Level 2 Qualification, Mechanical and Electrical Level 3 Qualification, General Contractor of Construction Level 3 Qualification

◆ Have a safety production license

◆ Self-built professional safety management system

◆ Zero major safety accidents since 18 years

3、60 technicians of all kinds

60 technicians of all kinds

◆ We can design and build high level GMP workshop class A and class 1 clean room

◆ Tailor-made design solutions

◆ Project design are strictly implement GB50073-2013\GB 50473-2008\GB50457- 2008 and other national standard clean specification and the United States federal 209E standard

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Third party acceptance test verification

4、Third party acceptance test verification

◆ Self-provided full set of testing instruments, first self-test after third-party testing

◆ The project construction strictly implements national GMP, US FDA and EU Euro GMP and other domestic international standards.

Customer Focused

5、Customer Focused

◆ Complete standardized process to ensure the construction period and quality

◆ One year after the warranty period, take the initiative to visit 2 times and 1 time at home

◆ We are convinced that our work is only valuable if the users are satisfied.

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