Cleanroom Design

کتاب های و استانداردهای مورد استناد در مشاوره،طراحی صنایع دارویی و تجهیزات پزشکی

 

ردیف

نام مدرک

شرح

1

ASTM E2500

Standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment 

2

DIN EN 1886

Ventilation for buildings - air handling units - mechanical performance 

3

راهنمای هواساز 

انجمن سازندگان هواساز آلمان 2011،                                     Incl. new VDI 3803 Sheet 1
new DIN EN 1886
Amendment to DIN EN 13053
Energy efficiency classes A+, A, B

4

BS EN 13053

Ventilation for buildings - Air handling units - Ratings & Performance for units, Components and sections

5

EU GMP

The European Union's GMP

6

cGMP

current good manufacturing practices (cGMP)

7

PIC/S GMP

PIC/S GMP Guide

8

سازمان بهداشت جهانی

جی ام پی - تهویه HVAC

9

مهندس مشاور خارجی و سازمان بهداشت جهانی

جی ام پی، اتاق تمیز تهویه HVAC

10

سازمان بهداشت جهانی

جی ام پی - یک دوره کامل

11

ISO 14644-1

Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness

12

ISO 14644-2

Cleanrooms and associated controlled environments - part 2: specifications for testing and monitoring

13

ISO 14644-3

Cleanrooms and associated controlled environments - part 3: test methods

14

ISO 14644-4

Cleanrooms and associated controlled environments - part 4:design,construction and start-up

15

ISO 14644-5

Cleanrooms and associated controlled associated controlled - part 5: operations

16

ISO 14644-6

Cleanrooms and associated controlled environments - part 6: vocabulary

17

ISO 14644-7

Cleanrooms and associated controlled environments - part 7: separative devices

18

EN 1822-1

High efficiency air filters (epa, hepa and ulpa) part 1: classification, performance testing, marking

19

EN 1822-2

High efficiency air filters (epa, hepa and ulpa) part 2: aerosol production, measuring equipment, particle counting statistics

20

EN 1822-3

High efficiency air filters (epa, hepa and ulpa) part 3: testing flat sheet filter media

21

EN 1822-4

High efficiency air filters (epa, hepa and ulpa) part 4: determining leakage of filter elements (scan method)

22

EN 1822-5

High efficiency air filters (epa, hepa and ulpa) part 5: determining the efficiency of filter elements

23

EN 779

Particulate air filters for general ventilation - determination of the filtration performance

24

ANSI/ASHRAE 52.1

Gravimetric and dust-spot procedures for testing air-cleaning devices used in general ventilation for removing particulate matter

25

ANSI/ASHRAE 52.2

Method of testing general ventilation air-cleaning devices for removal efficiency by particle size

26

FED-STD-209D

Cleanroom and workstation, requirements, controled environment

27

FED-STD-209E

Airborne particulate cleanliness classes in cleanrooms and clean zones

28

ISPE

Ispe baseline guide: commissioning & qualification

29

ISPE

Ispe baseline guide: sterile manufacturing facilities

30

ISPE

Ispe baseline guide: water & steam systems

31

ISPE

Commissioning & Qualification of Pharmaceutical water & Steam Systems