1. 1 GENERAL BEHAVIOR AND ASEPTIC PRACTICES SANTOSH KUMAR KARMAKAR OCTOBER- 12 th 2013

2. 2 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  An underlying assumption in persuasion (Arguments) research is: Shift a person’s attitude in the right direction and behavior will follow. Examples: If people see the value of wearing their seatbelt then they are more likely to actually wear it. If people think that smoking is bad for their health then they will quit. Relationship between attitude toward cheating and actually cheating close to zero. Those who did poorly more likely to cheat. Certain peoples’ attitudes are more consistent with their behaviors than others. Example: High Self Monitors A high self monitor changes their behavior depending on the situation. A low self monitor behaves the same way across situations. Are you a high self monitor?

3. 3 GENERAL BEHAVIOR AND ASEPTIC PRACTICES On average, people believe that they are above average. People take credit for their success but attribute failure to external/ situational factors. Egocentric bias in groups such that each person believes they contributed more than any other person. Asking yourself questions like: Is it helpful to the person for me to think that? What evidence do I have for thinking this? Is this a belief I want to continue to hold on to?

4. 4 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Sepsis, Asepsis or Aseptic? Aseptic Behavior or Technique?  Sepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms.  Asepsis or Aseptic is the state of being free from disease-causing contaminants (such as bacteria, viruses, fungi, and parasites) or, preventing contact with microorganisms.  Aseptic Behavior or Technique ? Aseptic Technique is the process by which a sterile (aseptic) product (typically food or pharmaceutical) is packaged in a sterile container in a way that maintains sterility.

5. 5 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Aseptic Technique requirements ?  Aseptic Technique requires “A strict design regime (System), not only on the process area, but on the interactions with surrounding areas and the movement of people, materials and equipment so as not to compromise the aseptic conditions.”  The four pillars of a robust * aseptic process or Technique. Personnel training & monitoring Environmental monitoring Facilities design & HVAC validation Process simulation (media fills).  Sources of Contamination?  Three primary Sources are: Personal, Air and Water.  Air & Water can be controlled by means of high quality automated system. Personal involvement and controlling of aseptic states are very critical.

6. 6 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Why Personal Involvement are risk to aseptic processing? The normal range of breaths per minute for an adult (relaxed) is between 9 and 14, one breath meaning one movement of the chest, up and down. Normal Human exhale 40,000 parts per million (ppm) of CO2 with every breath? The skin is home to a virtual zoo of bacteria, Dry skin can have 1000’s of microbes / mm 2 ! Bacteria are found in the intestines, eyes, mouth, hair and skin of the human. Human saliva can have up to 1 billion per mL.  Over 200 different species of bacteria are found associated with humans. Outer layer of human skin can host up to 1 million microorganisms per square cm.

7. 7 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Major Potential source of microbial Contamination:- Exposed skin (flakes, Oils). Hair. Clothing fibers. Dirt. Cosmetics. Tobacco smoke. Behavior.

8. 8 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Particles shed from Human Body:- Small size of particles means that gravity has lesser effect; think cigarette smoke, Can remain in turbulent eddy currents for long Periods. Activity Particles / minute 0.3 µ and larger Motionless (Standing / Seated )100000 or 1 lac/min Sitting, Small movement of arms or head500000 or 5 lac/min Sitting, moving arms, legs or head1000000 or 10 lac/min Standing Up2500000 or 25lac/min Walking Slowly5000000 or 5lac/min Walking Normally7500000 or 7.5lac/min Walking speed 2.5m/s10000000 or 1.0 Koror/min Horse Play100000000 or10.0 Koror/min

9. 9 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Air born Particle & Water can be controlled by means of high quality automated system. Personal involvement in aseptic process are very critical to remain Aseptic state to Aseptic.  If people are a major source of contamination how do we avoid contaminating the product while we process it? “By adhering Clean Room Concept “  What is a clean room? (As Per ISO 14644-1) A room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles & microbes inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.

10. 10 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  General Clean room Regulations No personal items such as jewelry, keys, watches, matches, lighters and cigarettes. No eating, smoking or gum chewing. No cosmetics such as lipstick, eye shadow, eyebrow pencil, mascara, eye liner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes. Approved skin lotions are sometimes allowed to reduce skin flaking. Avoid clean rooms when ill.

11. 11 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Actions Prohibited in Clean rooms Fast motions such as running, walking fast or horseplay. Sitting or leaning on equipment or work surfaces. Writing on equipment or garments. Removal of items from beneath the clean room garments. Wearing torn or soiled garments. Allowing hands to touch anything other than product-related work.

12. 12 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Minimizing particles Only approved clean room paper. Only approved ball point pens for writing. Use of paper or fabric towels are prohibited. Two surfaces rubbing generates billions of particles per cubic ft. Equipment should be specialized for clean room use. An open, non-air locked door can add billions of particles per cubic ft.  Interlocking door system Door to “dirtier” area must be closed before door to “clean” area can be opened. Personnel must come in and out of the clean room through the gowning room. buffer zone.

13. 13 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Cleaning the Clean room Cleaning is the essential element of contamination control. Disinfectants filtered. Mops/Buckets autoclaved. Disinfectants rotated every two weeks. Only clean room approved wipers allowed. Clean top to bottom, cleanest area to dirtiest

14. 14 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Clothing of appropriate quality: Grade D: hair, beard, moustache covered, protective clothing and shoes. Grade C: hair, beard, moustache covered single or 2-piece suit (covering wrists, high neck), shoes/over shoes. no fibres/particles to be shed Grade A and B headgear, beard and moustache covered, masks, complete gowning, gloves not shedding fibres, and retain particles shed by operators. Outdoor clothing not in change rooms leading to Grade B and C rooms.

15. 15 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Objective of Aseptic processing: Objective is to maintain the sterility of a product, assembled from sterile components. Operating conditions so as to prevent microbial contamination.  Note to maintain Aseptic environment: If a sterile object touches a non-sterile object, it is no longer sterile. The edge of a sterile field and 1-2 inches inward is not sterile. The skin is not sterile. Anything you cannot keep in your line of vision (therefore, cannot control) is not sterile. Below the waist. Your back. Below the edge of the table. Single-use items are only used once. Do not touch critical parts of equipment during procedure.

16. 16 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  To maintain Aseptic environment : Clean room environment is very fragile (Easily Broken) ! Your actions have impact on other users. Do not cross over the sterile field (by any parts of the body). Do not cough, sneeze, or talk excessively over a sterile field. Sterile instruments should be held under Class 100 conditions between uses and placed in sterile containers. Operators should not contact sterile products, containers, closures, or critical surfaces with any part of their sterile gown or sterile gloves.

17. 17 GENERAL BEHAVIOR AND ASEPTIC PRACTICES  Aseptic Awareness ( Correct and In Correct Techniques): What’s wrong with this picture?

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34. Gloving Technique

42. 42 Questions, please…. ? GENERAL BEHAVIOR AND ASEPTIC PRACTICES

43. 43 …………..THE END………….. THANKS FOR YOUR ATTENTION GENERAL BEHAVIOR AND ASEPTIC PRACTICES