Air conditioning purification in the clean room of Zhang Liqun Pharmaceutical Factory (new GMP)

eye record

1、 Basic knowledge of clean room

（1） What is a clean room

（2） The four major technical elements of a clean room

（3） Classification of Cleanrooms

（4） Cleanroom cleanliness level standard

（5） The occupancy status of the clean room

（6） Pollution Sources and Control in Cleanrooms II. AboutGMP

(1)GMPThe History of Development

（2） New versionGMPCharacteristics of

(3)new versionGMPand1998 年版GMPDifference 3: Air conditioning purification design for pharmaceutical cleanrooms

（1） Preparation work before design

（2） Layout plan of clean rooms for pharmaceutical production

（3） Air conditioning purification system and exhaust system

（4） Three major balance calculations for air conditioning purification systems

（5） Optimization of Air Treatment Scheme for Air Conditioning Purification System

（6） Calculation of total cooling capacity, total heating capacity, and total humidification capacity of air conditioning purification system

（7） Selection of air conditioning and purification equipment

（8） Drawing of construction drawings

4、 Confirmation and validation of pharmaceutical cleanrooms

（1） Confirmation and verification of pharmaceutical manufacturing enterprises

（2） The confirmation of pharmaceutical clean rooms can be divided into:

（3） Monitor the cleanroom of the pharmaceutical factory in a normal and dynamic manner

（4） Validate the drug production process

（5） Static testing items for clean rooms V. Appendix

Appendix1 The main content emphasized in "sterile drugs"

Appendix2 The main content emphasized in "active pharmaceutical ingredients"

Appendix3 The main content emphasized in "biological products"

Appendix4 The main content emphasized in "blood products"

Appendix5 The main content emphasized in "Traditional Chinese Medicine Preparations"