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June 2015
& Cross& Cross
ContaminationContamination
Sreenath.SSreenath.S
QC-Micro
WelcomeWelcome
Microbial Impacts on Prod...
-He successfully introduced carbolic acid (now
known as phenol) to sterilize surgical
instruments and to clean wounds, whi...
  
Definition of Cross-Contamination
Cross-Contamination is the presence in a particular
product of small, traceable quant...
  
Types of contamination:
1.Physical: Ex. Particles/ Fibers /Paint flakes/ Metal parts
2.Chemical: Ex. Moisture/gases/ Mo...
  
Biological contamination is due to :
Improper sanitization of hands
Improper Gowning procedures
Open Lesions
Suffering ...
  
FDA-RECALL- Physical Contamination  
  
FDA-RECALL- Physical Contamination  
  
FDA-RECALL- Chemical Contamination  
  
FDA-RECALL- Biological Contamination  
Gowning ProceduresGowning Procedures
• What are contaminants?
• Contaminants are the presence of anything in the
manufactured product which should not be there...
  
Cross-contamination:
  
Where Do Contaminants Come From?
• Outside air carries dust which is a contaminant
• People generate contaminants:
We ...
Why All the Concern About Dust?
Typical size relationship between 
dust, bacteria and viruses
Virus 
(0,006µm to 
0,03µm)
...
  
Removal of Dust
• As dust is a carrier, dust must be controlled.
• Ambient bacteria is removed by filtration.
• Interna...
  
Environment
Temp. & RH
Pressure Differential
Air velocity
Air changes
Filter Integrity
Viable & Non-Viable particles
HV...
  
Microbial contamination of pharmaceuticals
A pharmaceutical raw material is an active or inactive
substance used in the...
  
Microbial contamination of pharmaceuticals
Most raw materials for pharmaceutical products support
some forms of microbi...
  
  
Contamination
Contaminants 
from
Environment
& Operators
Contaminants 
from 
Equipment
Cross
Contamination
Product
from...
  
• Cross-contamination  is a sure indication of bad 
practices,  as it shows that there is insufficient control
over,
1....
  
Cross-contamination can be minimized by
1. Personnel procedures (Skilled Manpower, Technical
Awareness)
2. Adequate pre...
  
Prevention of Cross-contamination during Processing
Clothing/ Gowning/PPE
Proper washing of cloths
Dedicated clothing f...
  
Bata-Lactam
Cross contamination
Separation from BP to GP
-penicillin products may cross contaminate other
medicines
-cr...
  
Bata-Lactam
Cross contamination
Separation from BP to GP
-The cGMP requires that production of penicillin and
other pre...
  
21 CFR 211.42(d), 211.46(d), and 211.176.
Non-penicillin beta-lactam drugs also may be
sensitizing agents. Cross-contam...
  
Bata-Lactam
Cross contamination
(Attix Pharma, Canada- June 2015)
  
Bata-Lactam
Cross contamination
FDA -483 (Attix Pharma, Canada- June 2015)
  
Bata-Lactam
Cross contamination
FDA -483 (Attix Pharma, Canada- June 2015)
  
CAUSIONS 
House keeping 
AHU/HVAC Systems
Personnel Hygiene
Microbial Monitoring
cGMP
FDA SURPRISE VISITFDA SURPRISE VISIT
  
Post Script....!!!!
The challenge in aseptic processing is always 
personnel:
•As a source of
microbial and
particle
co...
  
Do U Really Wanna Screw UP….???? 
THANKSTHANKS
FOR YOURFOR YOUR
KIND ATTENTIONKIND ATTENTION
Microbial Impacts on Pharma Products & Cross Contamination
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Microbial Impacts on Pharma Products & Cross Contamination

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Microbial Impacts on Pharmaceutical dosage forms & Cross Contamination.

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Microbial Impacts on Pharma Products & Cross Contamination

  1. 1. June 2015 & Cross& Cross ContaminationContamination Sreenath.SSreenath.S QC-Micro WelcomeWelcome Microbial Impacts on ProductsMicrobial Impacts on Products
  2. 2. -He successfully introduced carbolic acid (now known as phenol) to sterilize surgical instruments and to clean wounds, which led to a reduction in post-operative infections and made surgery safer for patients. By applying Louis Pasteur's advances in microbiology, he promoted the idea of sterile surgery (pioneer of antiseptic surgery) "Kills germs that cause bad breath"
  3. 3.    Definition of Cross-Contamination Cross-Contamination is the presence in a particular product of small, traceable quantities of other pharmaceutical products manufactured at the same time in the same premises previously on the same equipment or in the same premises Definition of contamination: The introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (e.g., occurring during production, sampling, packaging or repackaging, storage or transport).
  4. 4.    Types of contamination: 1.Physical: Ex. Particles/ Fibers /Paint flakes/ Metal parts 2.Chemical: Ex. Moisture/gases/ Molecules/ vapors 3.Biological: Ex. Microorganisms Examples of Cross-contamination: 1.Physical: Ex. Leakage of oil seal form the reactor 2.Chemical: Ex. If a product exposed to a high RH environment---- Increase in Moisture content 3.Biological: Ex. Improper Cleaning of equipment/ Use of unclean equipment for the process
  5. 5.    Biological contamination is due to : Improper sanitization of hands Improper Gowning procedures Open Lesions Suffering from Infectious diseases Use of contaminated water for cleaning equipments
  6. 6.    FDA-RECALL- Physical Contamination  
  7. 7.    FDA-RECALL- Physical Contamination  
  8. 8.    FDA-RECALL- Chemical Contamination  
  9. 9.    FDA-RECALL- Biological Contamination  
  10. 10. Gowning ProceduresGowning Procedures
  11. 11. • What are contaminants? • Contaminants are the presence of anything in the manufactured product which should not be there. • Contaminants can originate from: • Environment (particles, micro-organisms, dust containing other products/materials) • Equipment (residues of other products, oil, particles, rust, gaskets, metal) and can be brought into the product by air movements. • Personnel
  12. 12.    Cross-contamination:
  13. 13.    Where Do Contaminants Come From? • Outside air carries dust which is a contaminant • People generate contaminants: We completely shed our outer skin every 24 hrs. Particles of 0,3 micron & greater are liberated at a rate varying between of 100 000 to 10 million per minute A person walking will liberate 5000 bacteria/minute and a single sneeze can produce up to 1 million bacteria. • The manufacturing process itself can generate contaminants • Ex. paint off equipment, dust from belt drives, etc ∆
  14. 14. Why All the Concern About Dust? Typical size relationship between  dust, bacteria and viruses Virus  (0,006µm to  0,03µm) Dust Particle (0,5µm to  500µm) Bacteria  (0,2µm to  2µm) Dust Is a Bacteria Carrier
  15. 15.    Removal of Dust • As dust is a carrier, dust must be controlled. • Ambient bacteria is removed by filtration. • Internal bacterial distribution can be controlled by directional air flow and air flushing or dilution. • Surface bacteria is controlled by adherence to strict cleaning sop’s.
  16. 16.    Environment Temp. & RH Pressure Differential Air velocity Air changes Filter Integrity Viable & Non-Viable particles HVAC Controls 
  17. 17.    Microbial contamination of pharmaceuticals A pharmaceutical raw material is an active or inactive substance used in the manufacture of a pharmaceutical dosage form. Non-sterile pharmaceutical products with a high degree of water content may be contaminated with microorganisms. The contaminating microorganisms may cause spoilage of the product with loss of its therapeutic properties.
  18. 18.    Microbial contamination of pharmaceuticals Most raw materials for pharmaceutical products support some forms of microbial growth, depending on the nutritive properties and moisture contents. Hence, dry powder or tablets are 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; Survival of microorganisms within pharmaceutical products The survival of microorganism in particular environments is sometimes influenced by the presence of relatively inert materials. Thus, microbes can be more resistant to heat or desiccation in the presence of starch, acacia or gelatin.
  19. 19.   
  20. 20.    Contamination Contaminants  from Environment & Operators Contaminants  from  Equipment Cross Contamination Product from Environment & Operators Product from Equipment
  21. 21.    • Cross-contamination  is a sure indication of bad  practices,  as it shows that there is insufficient control over, 1.Design of premises and systems quality 2.Air handling and dust extraction systems 3.Operation and maintenance of air handling and dust extraction systems 4.Procedures for cleaning of equipment and for restriction of movement of personnel 5.Procedures for cleaning of premises
  22. 22.    Cross-contamination can be minimized by 1. Personnel procedures (Skilled Manpower, Technical Awareness) 2. Adequate premises (Proper Lay out, Area Classification) 3. Use of closed production systems (Man & Material movement) 4. Adequate, validated cleaning procedures 5. Correct air pressure cascade (HVAC design & Air Distribution)
  23. 23.    Prevention of Cross-contamination during Processing Clothing/ Gowning/PPE Proper washing of cloths Dedicated clothing for sensitive products (Hormones)/BP/GP separate washing facility Minimize the exposed body surfaces Clothing/Linen should be changed after every product change over Utilities  Ensure monitoring of Water/Compressed air on a regular basis
  24. 24.    Bata-Lactam Cross contamination Separation from BP to GP -penicillin products may cross contaminate other medicines -cross-contaminated products can cause severe anaphylactic reactions and death in sensitive patients -more than one drug is manufactured in the same production line. This is the source of cross- contamination since residuals of former drug may be passed to the latter drug.
  25. 25.    Bata-Lactam Cross contamination Separation from BP to GP -The cGMP requires that production of penicillin and other preparations liable to be contaminated shall be carried out in dedicated areas Penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people.
  26. 26.    21 CFR 211.42(d), 211.46(d), and 211.176. Non-penicillin beta-lactam drugs also may be sensitizing agents. Cross-contamination with non- penicillin beta-lactam drugs can initiate the same types of drug-induced hypersensitivity reactions that penicillins can trigger, including life-threatening allergic reactions. Therefore, manufacturers of non- penicillin beta-lactam drugs should employ similar control strategies to prevent cross-contamination, thereby reducing the potential for drug-induced, life- threatening allergic reactions. Bata-Lactam Cross contamination Separation from BP to GP
  27. 27.    Bata-Lactam Cross contamination (Attix Pharma, Canada- June 2015)
  28. 28.    Bata-Lactam Cross contamination FDA -483 (Attix Pharma, Canada- June 2015)
  29. 29.    Bata-Lactam Cross contamination FDA -483 (Attix Pharma, Canada- June 2015)
  30. 30.    CAUSIONS  House keeping  AHU/HVAC Systems Personnel Hygiene Microbial Monitoring cGMP
  31. 31. FDA SURPRISE VISITFDA SURPRISE VISIT
  32. 32.    Post Script....!!!! The challenge in aseptic processing is always  personnel: •As a source of microbial and particle contamination. •As a brake on the implementation of improved technology.
  33. 33.    Do U Really Wanna Screw UP….????  THANKSTHANKS FOR YOURFOR YOUR KIND ATTENTIONKIND ATTENTION

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