An E coli strain being plated for identification Presentation Outline Important environmental monitoring data to collect and analyze Most common reasons for exceeding validated bioburden limits ID: 583544
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Slide1
Bioburden Failure Analysis
An
E. coli
strain being plated for identification.Slide2
Presentation OutlineImportant environmental monitoring data to collect and analyzeMost common reasons for exceeding validated bioburden limits
Containment & correctionsCorrective
actions
&
p
reventive actions
Conducting a supplier audit of environmental monitoring
Training
&
quality objectivesSlide3
What data should you collect?Important environmental monitoring data to collect and analyzeSlide4
Most Common CausesPeople not following gowning proceduresInadequate gowning procedures
Inappropriate storage conditions for componentsFailure to remove secondary packaging or clean primary packaging outside controlled environment
Failure to following cleaning schedule
Inadequate cleaning and preventive maintenanceSlide5
ContainmentWhich lots?If specific cause is unknown, there should be statistical rationale for the bracketing based upon sampling and trend analysis of bioburden.
Identify product and/or raw materials as nonconforming (i.e., initiate an NCR)Don’t contaminate your “good” productSlide6
CorrectionsRe-sterilization of product (if you do not have this validated, evaluate the adverse effects of re-sterilization)Conducting a recall
Scrapping productCleaning product (rework procedures with an evaluation of the adverse effects of rework)
Cleaning—a lot!Slide7
Corrective ActionsChanges to supplier environmental controlsChanges to raw material storage
RetrainingChanges to gowning proceduresIncreasing the frequency of cleaning
Changing the disinfection solution & creating a rotating schedule
More frequent replacement of HEPA filters
Where should hairnets be removed?Slide8
Where should hairnets be removed?Slide9
Preventive ActionsMost companies struggle to identify purely preventive actionsBioburden trend analysis is an excellent source
Don’t wait until you have an excurs
i
on.
Examples of Preventive Actions:
Monitoring raw material bioburden
Improved gowning procedures
Increasing the frequency
of
cleaning
Rotating disinfecting solutions
Preventive maintenance of HEPA filtersSlide10
Supplier AuditsSupplier qualification audits should be conducted on-site—not remotelyTypes of suppliers that should include a review of environmental monitoring, gowning and cleanroom cleaning procedures
Contract manufacturers of finished devicesContract packagersComponent suppliers for sterile devicesSlide11
When NOT to Audit RemotelyO
nsite visits facilitate the building of supplier-customer relationships.
T
ouring
facilities and watching demonstration of processes improves understanding of a supplier’s processes better than reading documents and records
can.
Cleanliness and capabilities of suppliers are best evaluated onsite, where camera angles can be used to crop out important details
S
ometimes
suppliers misrepresent their capabilities by showing photographs on their website of other companies.Slide12
“Witch Hunts”Supplier Audits “For Cause”Slide13
SCAR Effectiveness Check
http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit Slide14
If supplier delays SCAR…How do you monitor production processes?
Step 7
Output is the DHR for each production lot.
Input is the production work order or job order.
Step 2
Step 3
Step 5
Step 6
Sample calibration records. Sample maintenance records. Sample validation & re-validation records. Sample environmental monitoring and cleaning records.
Step 4
Step 1:
D
escribe the process for controlling production processes.
Reference supplier’s procedures and forms, including revisions of documents.
Sample training records for person(s
) performing manufacturing.
Look for effectiveness of training and competency
.Slide15
Remote Auditing“Any time you can audit in a conference room, you could probably do the audit remotely.”
http://medicaldeviceacademy.com/4-ways-make-best-use-remote-audits
/
Slide16
TrainingTrainingSlide17
Quality ObjectivesQuality objectivesSlide18
Q&ASlide19
Need help? Contact me.
Rob Packard
rob@13485cert.com
+1.802.281.4381
rob13485