1 General Provisions
1.0.1 This standard is formulated, with a view to following out the related national guideline / policies and "Good Manufacture Practice" (GMP), making state-of-art technology, economic application, safety and stability, and guaranteed quality, satisfying the requirements of energy conservation and environmental protection.
1.0.2 This standard is applicable to designs of new, extended and rebuilt pharmaceutical industry clean rooms.
1.0.3 The design of pharmaceutical industry clean room shall provide the necessary conditions for construction and installation, facilities validation, maintenance administration, overhaul test and safe operation.
1.0.4 The design of pharmaceutical industry clean room shall meet the provisions of the related national standards, besides this standard.
2 Terms
2.0.1 Pharmaceutical clean room (zone)
Room or space which the parameters, such as concentration of airborne particles and microorganisms, temperature, humidity and pressure, are controlled or restricted
2.0.2 Room for cleaning human body
Room where personnel shall be cleaned by a procedure before entering clean zone
2.0.3 Room for cleaning material
Room where materials shall be cleaned by a procedure before entering clean zone
2.0.4 Airborne particles
Solid and liquid particles used for air cleanliness grading, which are the airblrne particulates with the dimension 0.5 ~ 5 m
2.0.5 Microorganisms
Bacteria that can reproduce or transfer gene substance, or non-bacterial minute creature entity
2.0.6 Particle concentration
Unit volume granule number of airblrne particulates in air
2.0.7 Microorganisms concentration
Unit volume quantity of microorganisms in air
2.0.8 Air cleanliness
Clean degree graded by the unit volume quantity of particle and microorganisms in air
2.0.9 Air pattern
Flow form and distribution of indoor air
2.0.10 Unidirectional flow
Air flow along single direction in the form of parallel flow, which the air velocity is uniform on cross section
2.0.11 Non-unidirectional airflow
Air flow untrue to the definition of unidirectional flow
2.0.12 Mixed airflow
Air flow combined with unidirectional flow and non-unidirectional airflow
2.0.13 Air lock
Room arranged on the access door of clean room (zone) for obstructing air flow of outdoor or adjoining room and controlling pressure difference
2.0.14 Pass box
Opening, arranged on the dividing wall of white room, for transferring material and tools / instruments. The two doors that cannot be opened simultaneously are arranged on both sides hereof.
2.0.15 Clean working garment
Clean clothing minimizing the microorganisms or particles generated by staffs, and in which dirt and microorganisms amount is minimized
2.0.16 As-built
Facilities have been built up, and all powers put through and run without production facilities, materials and personnel
2.0.17 At-rest
Facilities have been built up and run, with equipped production facilities but materials and personnel, under the state required by owner and supplier
2.0.18 Operational
The facilities run under the specified state, and required personnel present work under the agree-upon state
2.0.19 High efficiency particulate air filter
Air filter, under the rated air volume, which has the arresting efficiency over 99.97% to the particle which the particle size is larger than or equal to 0.3m , and the gas-flow resistance under 254Pa
2.0.20 Process water
Water used in the production process of pharmaceuticals, including drinking water, purity water and water for injection
2.0.21 Purity water
Pharmaceutical water without any admixture, which are made by distillation, ion-exchange method, reverse osmosis or other proper methods
2.0.22 Water for injection
Water distilled from purity water
2.0.23 Fire-firing access
Exclusive entry into buildings for fire fighter fire-fighting
2.0.24 Cleanliness recovery characteristic
Time from the start-up of purification air-conditioning system to room restoring to the required stable indoor cleanliness, after white room is polluted
2.0.25 Sterile clean room
Clean room for sterile working
2.0.26 Airborne viable particles
Contents
1 General Provisions
2 Terms
3 Environmental Parameters of Production Area
3.1 General Requirements
3.2 Design Requirements of Environmental Parameters
4 Plant location and general layout
4.1 Plant Location
4.2 General Layout
5 Process design
5.1 Process Layout
5.2 Personnel Cleaning
5.3 Materials Cleaning
5.4 Process Water
6 Process line
6.1 General Requirements
6.2 Pipeline Material, Valve and Fittings
6.3 Installation and Insulation of Pipes
6.4 Safety Engineering
7 Equipments
7.1 General Requirements
7.2 Design and Selection
8 Construction
8.1 General Requirements
8.2 Firefighting and Evacuating
8.3 Indoor Decoration
9 Air Cleaning
9.1 General Provisions
9.2 Purified Air Conditioning System
9.3 Air Pattern and Air Output
9.4 Air Pipe and Attachment
9.5 Monitoring and Control
9.6 Special requirements of clean room used for production of medicine like penicillin
10 Water Supply and Drainage
10.1 General Provisions
10.2 Water Supply
10.3 Drainage
10.4 Fire Fighting Device
11 Electric
11.1 Electric Power Distribution
11.2 Lighting
11.3 Communication
11.4 Electrostatic Protection and Grounding
Annex A Examples on Air Cleanliness Class of Pharmaceutical Environment
Annex B Maintenance and Administration of
Annex C Validation of Pharmaceutical Clean Room (zone)
Explanation of Wording in this code
