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55 Cards in this Set
- Front
- Back
Differentiation of the facility risk level with the risk assessment. 2 Statements |
2. A risk assessment is completed while developing the sample plan and determining viable sample site locations. CAG refers to the FDA Aseptic Guidelines, "Therefor the number of sample locations is increased in areas where there is a greater potential for contamination to product." |
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Activity Level 3 Statements |
Do not confuse activity level with "passive" air sampling (use of settling plates) or "active" air sampling (volumetric sampling). If concern for product contamination, sampling can be conducted during media fills or while producing product that will go unused. |
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For information regarding the appropriateness of an active air sampler refer to ???
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ISO 14698-1:2003(E) Annex B Guidance on Validating Air Samplers. Request a copy of the ISO compliance validation document from the manufacturer. |
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MPN is ??
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A statistical correction that must be applied to air sample data if the manufacturer has indicated one. Make sure the lab applies it for you. |
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When using duplicative plate methods, what should you discuss with lab? |
Bacterial colonies may be recovered on mold plates, mold on bacterial plates. This may go unreported and may be considered a failure. Discuss how to handle before submitting samples. |
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What are the two types of gloved fingertip sampling requirements of USP <797> Pharmaceutical Compounding- Sterile Preparations? |
1. Gowning Evaluation 2. Gloved fingertip sampling (described as completed at end of a media fill preparation). Study Guide Author suggests sampling can occur at the end of a preparation also. Acceptance criterion for the Gloved fingertip sampling is not more than 3 CFU/glove. |
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Definition: Backwash Area
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Areas in a cleanroom that introduce particles and/or interfere with the intended patterns of airflow due to equipment placement, personnel flow, personnel operations and/or cleanroom design. |
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Definition: Contact Plates
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A convex sampling device containing a growth media supplemented with neutralizers used to sample surfaces for viable organisms. |
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Definition: Swab |
used to sample uneven surfaces for viable organisms. Assure it contains an appropriate neutralizer. |
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Definition: Viable |
Capable of living, developing, or germinating under favorable conditions. |
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4 Statements. |
2. Calibrated and disinfected- capable of collecting up to 1000L or more of air with sufficient rate that will not dry media. 3. Sampler must not interfere with air flow patterns of PEC which could introduce contamination. 4. Procure media filled strips or plates appropriate for the sampler. |
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What is important about neutralizers? |
Document all cleaners used in that cleanroom and compare to neutralizer used in your media to determine if capable of neutralizing those chemicals.
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4 general items. |
1. Should be a known manufacturer. 2. Accompanied by c of a w/ documented results of QA testing. 3. Double or triple bagged and irradiated. 4. If not terminally sterilized, then each plate must be pre-incubated (might dry out media!) |
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Media How to deem acceptable? Best Practice? |
2. perform sterility and growth support testing. 3. One positive, one negative control. 4. Per media, per lot and per shipment. 1. Include two pieces unopened media. |
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Facility Risk Level 3 items. |
2. Outlined by USP <797> 3. If more than 1 risk level, test to the highest risk level |
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Sampling Plan 5 items. |
2. Must include all areas and ancillary areas where compounding occurs (e.g. nursing, OR, etc) 3. Areas that pose the greatest risk of contamination to product must be included. 4. Samples in all PECs as well as areas of close proximity. 5. Most air samples at working height (some samples different, e.g. sampling a backwash area). |
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Areas posing greatest risk:
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PEC, buffer, ante, pass thorough, etc. Consider backwash areas and CSP pathways. Identify backwash areas with smoke studies. |
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10 items! |
2. Recommended after initial certification procedures BUT prior to recertification to provide "as found" 3. after any situation impacting operation of CR or PEC 4. after moving equipment 5. after servicing 6. after patient incident where CSP suspected 7. After changes to process affecting CR 8. After observation of incorrect work practices 9. After identified problems with end product 10. Significant changes to work flow or new procedures/equipment. |
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Air Volume
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1000L min ISO 5 400L min 7-8 Not acceptable to do 500L TSA and 500L SDA for for ISO 5. |
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3 items |
Surface sample AFTER compounding/competency testing Static sampling may be performed for information. |
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Documentation of Sampling Protocol 12 items |
2. volume 3. ISO classes 4. method of collection 5. frequency 6. activity level 7. action levels 8. response to exceeded levels 9. media type(s) 10. risk level 11. lab analysis 12. incubation time/temperatures |
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Sampling Plan/ Map 3 items. |
types of samples Must be taken in same areas each time for trending to be meaningful. |
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Chain of Custody: Generally included info: 11 items |
Volumes facility name/code tech name/initials date/time of sampling media types, lot, exp alert/action levels ISO Classification requested microbial testing name of your company! contact info |
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Chain of Custody: Best Practice 5 items |
2. equip SN, cal date 3. ISO class 4. Time 5. Any deviations from normal procedures that may impact results |
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Sample Plate Labeling: 6 "should" items |
2. facility name or code 3. media type 4. sample type (air vs surface) 5. volume if appropriate 6. labeled on bottom, NOT the lid |
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Report 10 items best practices= 4 items |
2. results indicating any presence of objectionable organisms 3. ID to at least genus level 4. growth promotion/sterility test results 5. media lot/exp 6. alert/action levels 7. date/time of sampling 8. activity level 9. pass/fail status 10. signature of lab analyst AND reviewer Additional info best practice: equipID, calibration, ISO class, incubation time/temp |
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Sampling Procedures: General Items 10 items. |
2. Disinfect all instruments, cart, materials when transferring into cleanroom. 3. Disinfect staging area. 4. Examine media for growth and integrity. 5. Sample clean to least clean. 6. Label plate 7. Disinfect gloves before/after each sample 8. Disinfect sampler head periodically and when possibly compromised 9. Aseptically handle- when in doubt throw it out (but not in controlled environment) 10. Controls travel with samples, and are not opened. |
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Sampling Procedures Best Practice
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Viable should occur prior to other testing criteria. |
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Examining Media: 5 items. |
2. missing sections 3. dryness (pull away from edge) 4. excess moisture 5. verify convex surface I'd also add type/expiration |
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6 items |
2. Select volume 3. Aseptically load. 4. Move to location. 5. Operate (according to manual) 6. Remove, replace and secure lid. |
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3 items |
2. Roll convex agar surface: in one direction across surface of site immediately replace lid 3. Apply brief spray 70% IPA and wipe or use pre-saturated wipe. |
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Surface sampling with Swabs 4 items |
2. Scrub using a twisting motion. 3. Entire area (up to 2" x 2"). Document size of sample area. 4. Apply brief spray IPA, wipe. |
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Isolator Specifics
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2. DO NOT sample surface of pass through or main chamber where equipment has been placed. 3. Compounding personnel simulate compounding while air sampler is running. 4. When simulation/competency is complete, personnel perform gloved fingertip sampling on both hands. DO NOT disinfect gloves prior. 5. All gloves present must be tested (i.e. for 3 glove CAIs) 6. Don't remove air sampler until simulation/competency is complete. 7. After compounder removes arms, then perform surface sampling. 8. Work from main chamber to transfer. 9. Load/unload in main chamber. |
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5 items |
2. NOT unreasonable to expect ISO 5 is operating correctly and sampled correctly. 3. If not met, can trend. 4. If isolator in uncontrolled space, PT cannot exceed ISO 8 5. If isolator in ISO 8 space, PT cannot exceed ISO 7. |
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Transporting Samples 9 items. |
1. Stack together. Lids can't come off. 2. Keep cool, but not frozen 3. NO DRY ICE 4. Samples can't touch ice pack 5. Can be repackaged in bag given by supplier 6. should be transported/stored inverted to minimize condensation 7. Must ship overnight 8. Samples should ship overnight, but not longer than 4 days and must be refrigerated prior to shipping 9. Package to prevent contamination |
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Growth Promotion: Bacterial Media 3 items |
2. Incuate not more than 3 days at 30-35C. 3. OK if clearly visible typical growth for each organism within allotted time. |
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Growth Promotion: Fungal Media 3 items |
1. Innoculate < 100 cfu Aspergillus brasiliesis and candida albicans in individual portions. 2. Incubate no more than 5 days at 20-25C 3. Clearly visible growth within allotted time for each organism |
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Media Sterility Testing
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OK if no growth. |
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Sample Incubation: Single Plate
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1. Invert at 30-35C for 48-72 hours then 26-30C for 5-7 days. |
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Duplicate Plate Method: |
General micrbiological media Incubate 30-35C for 48-72 hours inverted Mycological media or other media capable of supporting fungi: 26-30C for 5 -7 days inverted |
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Analysis of Samples: Single Plate Method
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2. After second incubation, removed and count ALL recovered colonies |
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Analysis of Samples: Duplicate Plate Method
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Count recoved mold/yeast on plates uncubated at 26-30. Add bacterial/fungal plate CFUs for each location. |
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Analysis of IDs:
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2. Determine if any coag positive staph. 3. Determine if any mold, yeast, gram negative rods, coag positive staph. |
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Swab total microbial count
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Add bacterial/mold yeast counts and multiply by the dilution factor |
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Data Expression |
2. Contact=CFU per plate 3. Swabs= CFU/swab or /area sampled 4. Zero CFU= "<1 cfu/plate" |
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Pass/Fail
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Gowning/Gloving >0 ISO 5 Air >1 ISO 5 surface >3 7 air >10 7 ss >5 8 air >100 8 ss >100 |
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Pass/Fail on ID
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Recovery of mold, yeast, coag + staph, or gram - rods considered not to be in compliance with USP <797> and requires immediate remediation and investigation into cause. |
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If report exceeds action levels:
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2. Personnel responsible for: cleaning resample
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Review
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Analyze periodically (usually yearly) and set appropriate alert/action levels. |
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Gowning Evalation: Frequency |
Low and medium: Annually thereafter (and only one trial) High risk: SEMI annually thereafter, one trial. |
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Gowning Evaluation: Isolator specifics
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2. If replace gloves prior to compounding, do that prior to sampling. 3. If donning sterile gloves inside isolator prior to compounding, do that. |
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Gowning Evaluation: 6 items |
2. Complete a written test 3. Must be observed gowning 4. Touch all four fingers and thumb on surface of plate. Enough for light impression without cracking/breaking media. Repeat with other hand (different plate) 5. Degown. 6. Repeat 3 times initially. |
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Gowning Evaluation: Incubation 2 items! |
2. Best practice: Also incubate 20-25C x 5-7 days more for mold. |
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Gowning Evaluation Pass/Fail
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Zero CFU and passing written test. |
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THE END |
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