This document outlines personnel hygiene and gowning/de-gowning procedures for pharmaceutical manufacturing. It discusses the importance of sanitation, hygiene, and avoiding cross-contamination. Key points include health examinations and training for personnel, protective clothing and hair coverings, separate changing areas, and procedures for safely donning and doffing gowns to prevent contamination. The goal is to maintain sanitary conditions and protect both personnel and products.

1. PERSONNEL HYGIENE AND
GOWNING & DE-GOWNING PROCEDURE
Md. Tanbirul Islam
Global Regulatory Incharge
Drug International Ltd. (Unit-2)

2. OUTLINE
 Definition
 Personnel Hygiene
 Design of Premises
 Operations
 Procedures
 Avoidance of Cross-Contamination
 Waste Disposal
 Conclusion

3. DEFINITION
 Hygiene : Conditions and practices that help to
maintain health and prevent the spread of disease.
 Sanitation : Hygienic control on manufacturing
processes, including personnel, premises,
equipment and handling of materials (from starting
materials to finished products).

4. SCOPE OF SANITATION & HYGIENE
 High level of sanitation and hygiene practiced in every
aspect of manufacturing.
 Personnel –direct operations and other staff
 Premises- vary with the operation
 Equipment and Apparatus
 Production materials and containers
 Materials for cleaning and disinfection
 All potential sources of cross –contamination

5. PERSONNEL HYGIENE
 Health Examinations:
 Before and During employment
 Periodic eye examinations- for those who do visual
Inspection.
 Training
 Practices in personnel hygiene
 Written procedure and instructions-Hand washing ,
disinfection etc.

7. PERSONNEL HYGIENE
 Illness or open lesions:
 May affect the quality of products
 Should not handle starting materials , intermediates or
finished products etc.
 Instruction and encouragement to report to supervisors
 Direct contact between product and operator:
 Should be avoided
 Starting Materials , Primary Packaging materials ,
Intermediate and bulk product

8. PERSONNEL HYGIENE
 Protection of product from contamination:
 Clean cloths appropriate to personnel activities
 Including hair Covering (e.g. Caps )
 Change Rooms/ Changing Facilities
 Hand Washing, drying of hands
 Used clothing stored in separate closed containers while
awaiting cleaning.
 Laundry of clean area clothing according to an SOP and
in an appropriate facility
 Procedure for disinfecting and sterilizing when required

9. PERSONNEL HYGIENE
 Personnel hygiene procedures including wearing
protective clothing apply to all persons entering into
production areas:
 Full time employees
 Temporary workers
 Contractors employees
 Visitors
 Managers
 Inspectors

10. PERSONNEL HYGIENE
 Protection of operator and product
 Special protective clothing for highly potent products.
 Personnel movement between areas producing different
products
 Garments cleaning
 Use of gloves

11. PERSONNEL HYGIENE
 Smoking , eating and drinking not allowed in production
areas, laboratories and storage areas
 No chewing (e.g. gum,) or keeping food or drinks
allowed
 No plants kept inside these areas
 Rest and refreshment areas should be separate from
manufacturing and control areas.

12. DESIGN OF PREMISES
 Depends on the
Activities
 Must prevent the build-
up of dirt and dust

13. DESIGN OF PREMISES
 Layout and Design
 Minimize the risk of errors
 Permit effective cleaning and maintenance in order to
avoid cross-contamination
 Build-up of dust or dirt
 Any adverse effect on the quality of products

14. DESIGN OF PREMISES
Walls, floors, ceiling, ledges, drains, air
supply , dust extraction
Cleaning, appropriate cleaning, Cleaning
records programme
Effective cleaning and disinfection
 Choice of materials and chemicals,
Validation

15. DESIGN OF PREMISES
 Toilets should not
open directly into
production or
storage areas

16. DESIGN OF PREMISES
 While drains are
inevitable in some
manufacturing areas,
they should be kept to
a minimum
 Should certainly not be
located in sterile areas
 Their design must prevent
the possibility of back-
flow.

17. DESIGN OF PREMISES
 Premises should be designed and equipped so
as to afford maximum protection against the
entry of insects ,birds, vermin or other animals ;
and weather. There should be a procedure for
rodent and pest control.
 From receipt of raw materials to dispatch of
released product.

18. DESIGN OF PREMISES
 Installation of a
ventilation system that
provides an appropriate
flow of air.
 Filtered incoming air
 Pressure differentials and
air extraction
 Air locks

19. OPERATIONS
 Cleaning and cleaning validation
 Degree of cleaning depends on whether consecutive
batches are of same or different product
 Cleaning agent is fully removed
 If possible hot water alone used for cleaning
 All cleaning and disinfecting solutions carefully prepared
and expiry dated.
 Final rinse with purified water, or water for injection
(for sterile products).
 Full records kept

20. OPERATIONS
 Maintenance and repair
 Activities inevitable in manufacturing area
 Should present no risk to product
 Whenever possible, all planned maintenance outside
normal operating hours
 Emergency work in working area followed by through
clean down and disinfection before manufacturing
recommences
 Area clearance by QA personnel.

21. AVOIDANCE OF CONTAMINATION & CROSS
CONTAMINATION
 Ventilation system & Airlocks
 Segregated areas / dedicated and self contained facilities
 Closed processing systems
 Cleaning and decontamination
 Special precautions to prevent generation and
dissemination of dust
 Campaign production
 Clothing

22. WASTE DISPOSAL
 Hazardous waste
 In a timely and sanitary
manner
 According to written
procedure

23. WHAT IS GOWNING
 Gowning:
The process of wearing special
garments in order to control particulate
contamination.
 Cross Contamination:
The process by which bacteria or other
microorganisms are unintentionally
transferred from one substance or
object to another, with harmful effect.

24. IMPORTANCE OF GOWNING & DE-GOWNING
 Protect the Product
 Self Protection
 Prevent Contamination

25. GOWNING SPECIAL INSTRUCTION
 Access to production area shall be permitted only through the
personnel entry wearing proper gowning.
 This attire shall not be worn outside the change area.
 Personnel shall be restricted from:
 Wearing nail polish or false fingernail.
 Wearing Jewelry, wrist watch, etc.
 Cosmetics, hair spray, perfumes
 Carrying mobile.
 Personnel in clean area shall wear clean all times during
production hours.

26. GOWNING AT HOME PREPARATION
 At Home Preparation
 Shower
 Shave
 Brush teeth
 Brush hair
 Proper attire
 Skin Moisturizers
 Practice good personal hygiene
 Select non shedding undergarment
 Select non shedding over garments

27. PRE-GOWNING AT WORK
 Report any medical conditions to supervisor
 Store all outer garments and personal belong
 separately and secure
 Remove all non-approved jewelry & store
 Remove all cosmetics
 Wash & dry hands
 Put on factory gowns, shoes/shoe covers

28. CONTAMINATION SOURCES AND CONTROL

29. CONCLUSION
 Sanitation & Hygiene requirements apply to
aspects of Pharmaceutical Manufacturing.
 Benefits and importance of sanitation & hygiene
in pharmaceutical manufacturing cannot be over-
emphasized in order to assure quality of the
products.