Page 68 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book

Pharm D- Clinical Pharmacy Program Third Level Pharmaceutical Microbiology& Antimicrobials (PM 502)

Control of microbial contamination during manufacture

Environmental cleanliness and hygiene

- All buildings should be maintained clean and dry

- Walls, ceilings and floors should have an impermeable and washable surface. free
from cracks and open joints.
- All equipment should be easy to clean.
- The manufacture in a closed system protects the product against airborne microbial

contamination
- Personnel:

• High standards of personal hygiene

• free from communicable diseases

• have no open lesions

• Adequate handwashing facilities

• protective garments

• gloves should be worn

• Staff should be trained in the principles of GMP
(Good Manufacture practice)

Environment Monitoring

• a program designed to demonstrate the control

of viable (living microrganism) and non-viable
particles in critical areas ( include

➢ clean-rooms for drug fill/finish, formulation tank
rooms, Intravenous (IV) compounding areas

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