Pharmaceutical Microbiology- Hygiene And Finger Dab Procedures

1. Quality Control-Microbiology
Training on hygiene & finger dab test
Sreenath.S
Site Microbiologist
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2. Over view of finger dab & hygiene
• Cleanliness of the personnel
• Maintenance of hygiene
• Proper hand sanitization
• Disinfectant cleaning
• Hand Swabbing
• Use of right sanitizer
• Growth of organisms
• Educating personnel's
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3. Why Is Hand Hygiene Important?
Hands are the most common mode
of pathogen transmission
Hand washing is an extremely important step
Hand washing significantly removes the
bacterial flora on the skin
Hand washing protects you and your patient
from the bacterial flora (from each other)
from becoming skin residents
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4. Hand Hygiene Definitions:
Hand washing
− Washing hands with plain soap
and water
• Antiseptic hand wash
− Washing hands with water and
soap or other detergents
containing an antiseptic agent
• Alcohol-based hand rub
− Rubbing hands with an alcohol-
containing preparation (used
after hand washing)
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5. When to Wash:
• Visibly dirty
• After touching contaminated
objects with bare hands
• Before glove placement and after
glove removal
Hand washing before and after each
operation is the single most important
hygiene measure for reducing or
preventing the spread of contamination
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6. Rings and Jewelry
• Hand jewelry should not be worn as
it may tear gloves and harbor
bacteria
− Studies have demonstrated that skin
underneath rings is more heavily
colonized than comparable areas of
skin on fingers without rings
− the more rings worn, the greater
concentration of organisms
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7. Fingernails
• Can affect the integrity
of gloves
• Can also harbor
bacteria
• Keep fingernails
SHORT!
− Avoid artificial nails
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8. Wash hands (or use and alcohol
based rub) before glove placement
and after glove removal.
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9. Hand Hygiene: Frequently Missed Areas
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10. Cleanliness of the personnel’s
• Always clean your hands before entering into manufacturing area
and where ever it is to be followed.
• Disinfectant the gloves during operation.
• Personnel Hygiene
• Illness
− Staff with illness or open lesions should
not handle starting materials,
intermediates or finished products
• Adverse conditions
− operators trained to recognize risks
− willingness to report illness to the area
supervisor
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11. Personnel Hygiene
Health examinations
– On recruitment for direct operators , repeated on
regular basis
• Training - check
– induction training for new operators includes
basic personal hygiene training
– written procedures - to wash hands before
entering a manufacturing area
– signs in changing rooms to reinforce hand washing
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12. Personnel Hygiene
• Contact between product and operator
avoid direct contact
if direct handling unavoidable, gloves
should be worn
check glove disinfection (for sterile
production) and disposal
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13. Personnel Hygiene
• Clothing and changing facilities
− check changing rooms (hand
washing, towels or hot air hand
dryers)
− check if used clothing stored in
separate closed containers while
awaiting cleaning
− laundering of clean area clothing
must be to SOP and in
appropriate facility
− check for procedure for sterilizing
and storing clothing for use in
sterile area
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14. FINGER DAB TEST
• Frequency:
• Once in six months
• Sampling plan: (Random sampling)
• Persons working in the manufacturing area are selected randomly from each
section on the day of the test.
• Limits:
• For Bacteria: Standard limit: NMT 100 cfu/Personnel
• Alert limit: NMT 50 cfu/ Personnel.
• Action limit: NMT 75 cfu/ Personnel.
• Fungi: Should be absent
• Pathogens: Should be absent
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15. FINGER DAB TEST DEMO
SAMPLE UNDER MICROBIAL
SWAB TAKEN BEFORE HAND WASH
TESTING
AFTER INCUBATION COLONIES ARE
IDENTIFIED
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16. FINGER DAB TEST DEMO
SAMPLE TAKEN AFTER HAND SANITIZATION SAMPLE UNDER MICROBIAL TESTING
AFTER INCUBATION NO COLONIES ARE
IDENTIFIED
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17. Taking off the first glove:
1.
2.
3.
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18. 4.
5.
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19. Taking off the second glove:
1.
2.
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20. 4.
3.
5.
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21. Disposal:
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22. THANK You………
Any Query ????????
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