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ASEPTIC AWARENESS Training Objectives: To further increase awareness about the microbial contaminants found on our bodies and in the environment. To discuss.

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Presentation on theme: "ASEPTIC AWARENESS Training Objectives: To further increase awareness about the microbial contaminants found on our bodies and in the environment. To discuss."— Presentation transcript:

1 ASEPTIC AWARENESS Training Objectives: To further increase awareness about the microbial contaminants found on our bodies and in the environment. To discuss behaviors to minimize contamination by personnel. To perform lab exercises to reinforce the concepts learned in class.

2 ASEPTIC AWARENESS Training What is Aseptic Processing? What processes are most vulnerable to contamination?

3 ASEPTIC AWARENESS Training Types of Contamination

4 ASEPTIC AWARENESS Training What are SPORES Why are they a A MAJOR CHALLENGE!!!!

5 ASEPTIC AWARENESS Training Sources of Contamination

6 ASEPTIC AWARENESS Training CONTROLLING contamination Facility design Personnel AND visitors wear gowns appropriately Personnel AND visitors behave appropriately

7 ASEPTIC AWARENESS Training Facility Design: Clean Area Classification

8 ASEPTIC AWARENESS Training Facilities: General Cleanroom Design HEPA/ULPA filters on ceiling Exhaust vents on floor Drains in aseptic processing areas are inappropriate Airlocks and interlocking doors to control air balance Seamless and rounded floor to wall junctions Readily accessible corners Floors, walls, and ceilings constructed of smooth hard surfaces that can be easily cleaned Limited equipment, fixtures and personnel Layout of equipment to optimize comfort and movement of operators

9 ASEPTIC AWARENESS Training Facilities: HEPA Filters High Efficiency Particulate Air Minimum particle collection efficiency: 99.97% for 0.3µm diameter particles. Disposable Filter made of pleated borosilicate glass microfiber

10 ASEPTIC AWARENESS Training Class 10,000 cleanroom Class 100 cleanroom Facilities: Cleanroom Classification

11 ASEPTIC AWARENESS Training Facilities: Cleanroom Classification

12 ASEPTIC AWARENESS Training Facilities: Pressure Differentials Used to maintain airflow in the direction of higher cleanliness to adjacent less clean areas A minimum of Pascals should be maintained between the aseptic area and an adjacent rooms with differing cleanroom classifications (doors open)

13 ASEPTIC AWARENESS Training Facilities: Air Lock Permits the passage of objects and people into a cleanroom. Consists of two airtight doors in series which do not open simultaneously.airtightdoors Spray down materials with 70% IPA before placing in the airlock

14 ASEPTIC AWARENESS Training Fiber-shedding materials such as cardboard and paper –Cardboard packaging must be removed and items placed into non-cardboard containers. Wood (i.e. wooden pallets) Undesignated charts Facilities: Material NOT permitted in a Cleanroom

15 ASEPTIC AWARENESS Training Facilities: Cleaning Water should be changed FREQUENTLY 1. Vacuum all accessible surfaces 3. Mop floors using a lint free polyester mops attached to stainless steel handles 2. Wipe surfaces with a cleaning solution

16 ASEPTIC AWARENESS Training Avoid Cleanrooms When Sick!!!

17 ASEPTIC AWARENESS Training Avoid cleanrooms when ill Frequent bathing and shampooing Avoid getting sunburned Avoid cosmetics such as face powder, hair sprays, perfumes and aftershave Clothing should be clean, nonfrayed and nonlinting Avoid smoking Personnel: Hygiene

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19 ASEPTIC AWARENESS Training FOREHEAD

20 ASEPTIC AWARENESS Training Personnel: Gloves When are gloves worn? What compromises gloves? How often should gloves be examined and sanitized?

21 ASEPTIC AWARENESS Training Qualifying Personnel Assess after gowning/gloving Microbiological surface sampling of several locations –Glove fingers –Facemask –Forearm –Chest –Periodic requalification is necessary

22 ASEPTIC AWARENESS Training Biological Safety Cabinets Small benchtop sized class 100 clean area

23 ASEPTIC AWARENESS Training Vertical Laminar Flow Area

24 ASEPTIC AWARENESS Training ISOPROPYL ALCOHOL Powerful disinfectant and antiseptic Mode of action: denatures proteins, dissolves lipids and can lead to cell membrane disintegration Effectively kills bacteria and fungi

25 ASEPTIC AWARENESS Training Particles >= 0.3µm emitted per minute Personnel Activity Snap Smock Membrane Coverall No Movement100,00010 Light Movement500,00050 Heavy Movement1,000, Change Position2,500, Slow Walk5,000, Personnel: Behaviour Austin Contamination IndexSource: Encyclopedia of Clean Rooms, Bio-Cleanrooms and Aseptic Areas, Dr. Philip Austin, PE, 2000 Minimize movement: Work slowly and purposefully Note: Light/heavy movement refer to partial body movements (motioning with arm, tapping toes, etc.). Change of position refers to whole body motion (standing up, sitting down, etc.).

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44 ASEPTIC AWARENESS Training ENVIRONMENTAL MONITORING In aseptic processing, one of the most important laboratory controls is the environmental monitoring program Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing -Current Good Manufacturing Practice, FDA, September 2004

45 ASEPTIC AWARENESS Training Microbial Monitoring Methods Touch or Contact plates –RODAC Plates Swabs Environmental Monitoring: Surface Monitoring

46 ASEPTIC AWARENESS Training Environmental Monitoring: Particulate Air Monitoring

47 ASEPTIC AWARENESS Training Active Air Monitoring RCS Plus Passive Air Monitoring Settling Plates RCS: Rotor Centrifugal Sampler Environmental Monitoring: Viable Microbial Air Monitoring

48 ASEPTIC AWARENESS Training Environmental Monitoring: Trending Data Why is it important? Evaluate the disinfection efficiency Are certain microbes migrating into the aseptic processing area from a lesser controller area? Long and short term Data by: –Shift –Room –Shift –Operator –Product –Container type –Filling line –Sampling –Testing personnel

49 ASEPTIC AWARENESS Training QC Micro: Identifying Microbes

50 ASEPTIC AWARENESS Training Gram Stain QC Micro: Identifying Microbes

51 ASEPTIC AWARENESS Training Metabolic Based Assays Vitek QC Micro: Identifying Microbes

52 ASEPTIC AWARENESS Training QC Micro: Identifying Microbes Metabolic Based Assays

53 ASEPTIC AWARENESS Training Staphylococcus xylosus Reduction of Tetrazolium Violet QC Micro: Identifying Microbes Metabolic Based Assays

54 ASEPTIC AWARENESS Training QC Micro: Identifying Microbes Metabolic Based Assays

55 ASEPTIC AWARENESS Training QC Micro: Identifying Microbes Genotype Based Assay: MicroSeq

56 ASEPTIC AWARENESS Training QC Micro: Identifying Microbes Genotype Based Assay: MicroSeq PCR: Polymerase Chain Reaction

57 ASEPTIC AWARENESS Training SEQUENCE THE DATA QC Micro: Identifying Microbes Genotype Based Assay: MicroSeq

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59 ASEPTIC AWARENESS Training Sepsis: Progression of Symptoms Fever Decreased Blood Pressure Rapid Breathing and Heart Rate Skin Lesions Spontaneous Blood Clotting Organ Failure Death

60 ASEPTIC AWARENESS Training QC Micro: LAL Assay

61 ASEPTIC AWARENESS Training Endotoxin MACROPHAGE Tumor Necrosis Factor Interleukins (1,6,8) QC Micro: LAL Assay

62 ASEPTIC AWARENESS Training ENDOTOXIN LIMIT FOR WFI IS 0.25EU/ml QC Micro: LAL Assay

63 ASEPTIC AWARENESS Training The Lysate QC Micro: LAL Assay

64 ASEPTIC AWARENESS Training Turbidimetric - increase in turbidity. Chromogenic - addition of a peptide that when cleaved during the assay turns a distinct color. Endpoint - Measure turbidity/absorbance after a definitive time period. Kinetic - Measure rate of increased turbidity/absorbance. Gel Clot – a clot forms and stays intact at the bottom of the assay tube when it is inverted QC Micro: LAL Assay TYPES of LAL ASSAYS

65 ASEPTIC AWARENESS Training This product was funded by a grant awarded under the President s High Growth Job Training Initiative as implemented by the U.S. Department of Labor s Employment & Training Administration. The information contained in this product was created by a grantee organization and does not necessarily reflect the official position of the U.S. Department of Labor. All references to non-governmental companies or organizations, their services, products, or resources are offered for informational purposes and should not be construed as an endorsement by the Department of Labor. This product is copyrighted by the institution that created it and is intended for individual organizational, non-commercial use only.


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