This presentation is about cross contamination and clean room practices.

1. CROSS-CONTAMINATION,
MIX-UP &
CLEAN ROOM PRACTICES

2. Different Terms
Contamination
• The undesired introduction of
impurities of a chemical or
microbiological nature, or of
foreign matter, into or onto a raw
material, intermediate, or API
during production, sampling,
packaging or repackaging,
storage or transport.
Cross
Contamination
• Contamination of a starting
material, intermediate product
or finished product with
another starting material or
product during production.
Mix-Up
• Mix of different items
but not necessarily
contaminated.

3. Contaminant:
Any particulate, molecular, non-particulate and biological entity that can adversely affect the product or process

4. Product to Product
Cross-Contamination

5. Cross
Contamination
Facility
Design
Equipment
Airflow
extraction
Manufacturing
Personnel
Clothing
Cleaning
SOURCES PREVENTION

6. SOURCES PREVENTION

7. Personnel Clothing

8. Personnel Clothing- Common errors

9. Personnel hygiene
Proper dress
• Clean uniforms
• No tears
• Closed toe shoes, no heels
• Clean foot ware
• Hair restraints
• No jewelry
• No visible body piercing
• No nail polish, false fingernails
• No false eyelashes
General Habits
• No eating
• No drinking
• No smoking
• No spitting
• No chewing gum
•Inform your supervisor if you
exhibit the any of the following
symptoms:
• jaundice (yellowing of eyes and
skin)
• diarrhea
• vomiting
• fever
• sore throat with fever
• boils or cuts
• discharges from ears, nose or
eyes
• excessive coughing or
sneezing.
Washing Habits
•Before starting to work
• After:
•Handling raw ingredients
•Smoking, eating or drinking
•Using a handkerchief or tissue
•Touching any dirty object or
surface
•Touching any part of your body
•Cleaning or taking out garbage
•Using the washroom

10. DUST CONTAMINATION (May be product dust)

11. Microbial contamination
A pharmaceutical raw material is an active or inactive substance used in the manufacture of pharmaceutical dosage form.
Non-sterile pharmaceutical products with a high degree of water content may be contaminated with microorganism.
The contaminating microorganism may cause spoilage of the product with loss of its therapeutic properties.
Most of the raw material supports some form of microbial growth depending upon the nutritive properties and moisture
contents.
Hence, dry powder or capable of undergoing some form of microbial spoilage or degradation. The more serious problem of
microbial contamination of tablets is where there are no obvious signs of spoilage

12. Air flow extraction-HVAC

13. Air flow extraction-HVAC

14. Air flow extraction-HVAC

15. Air flow extraction-HVAC
Vertical Laminar flowHorizontal Laminar flow
Laminar means Unidirectional

16. Cleaning Procedures

17. Cleaning Validation
Documented evidence that provides
high degree of assurance that an approved
Cleaning procedure will provide equipment
that is Suitable for processing of pharmaceutical
products

18. Cleaning Validation -MACO
MACO
Based on
Health
based
data
ADE /
PDE
Based on
TDD
Based on
toxicologi
cal data
(LD50)
Based on
general
limit 10
ppm
MACO : Maximum allowed carryover
ADE : Acceptable Daily exposure
PDE : Permitted daily exposure
TDD : Therapeutic Daily dose
LD : Lethal dose

19. Facility & Equipment

20. Manufacturing Process

21. CLEAN ROOM CONCEPT
An enclosed space in which the concentration of
airborne particulate, Contaminant and pollutants
is controlled to specified limits.

22. Sources

23. Mitigation

24. Cleanroom Classification
The classification of the room be carried out in different occupancy states.
As Built :
The condition where the installation is complete with all services connected and functioning, but with
no production equipment materials or personnel present.
At Rest:
The condition where the installation is complete with equipment installed and operating in a manner
agreed between the customer and supplier, but with no personnel present.
Operational:
The condition where the installation is functioning In the specified manner, with specified number of
personnel present and working in the manner Agreed upon.

25. Cleanroom Classification

26. Cleanroom Classification

27. Cleanroom Monitoring

28. Cleanroom Monitoring

29. KIRANREDDY MUNNANGI
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