rob packard, president [email protected] slide 1 of 23 bioburden failure analysis an e. coli strain...
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Bioburden Failure Analysis
An E. coli strain being plated for identification.
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Presentation Outline
• Important environmental monitoring data to collect and analyze
• Most common reasons for exceeding validated bioburden limits
• Containment & corrections• Corrective actions & preventive actions• Conducting a supplier audit of environmental
monitoring• Training & quality objectives
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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What to do first
• Double-check your math for calculation of bioburden and trend of bioburden
• Identify the organism(s) found• Confirm effectiveness of cleaning agent(s) on
organism(s) found• Re-sample work environment (duplicate
conditions of previous sample if possible)• Sample additional locations
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Records you should collect
• Raw data from environmental monitoring• Trend analysis of environmental monitoring• Identification of organisms found• Cleaning logs• Preventive maintenance logs• Temperature data logs• Device History Records• Training Records
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Documents you should collect
• Maps of controlled environment and warehouse– Location of personnel– Location of specific raw materials/components– Process flow
• Gowning procedure• Preventive maintenance procedure(s)• Cleaning procedure(s)
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Most Common Causes
• People not following gowning procedures• Inadequate gowning procedures• Inappropriate storage conditions for components• Failure to remove secondary packaging or clean
primary packaging outside controlled environment
• Failure to follow cleaning schedule• Inadequate cleaning and preventive maintenance
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Supplier Audits
• Supplier qualification audits should be conducted on-site—not remotely
• Types of suppliers that should include a review of environmental monitoring, gowning and cleanroom cleaning procedures– Contract manufacturers of finished devices– Contract packagers– Component suppliers for sterile devices
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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When NOT to Audit Remotely
• Onsite visits facilitate the building of supplier-customer relationships.
• Touring 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
• Sometimes suppliers misrepresent their capabilities by showing photographs on their website of other companies.
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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“Witch Hunts”
• Request copies of documents and records in parallel with requesting a supplier corrective action (SCAR)
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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SCAR Effectiveness Checkhttp://www.medicaldeviceacademy.com/supplier-auditing-tool-kit
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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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: Describe 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.
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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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/
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Root Cause AnalysisMaterials
Manpower
Mother Nature
Measurement
Machines Methods
Effect
6M’s
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Containment
• Which 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” product
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Corrections
• Re-sterilization of product (if you do not have this validated, evaluate the adverse effects of re-sterilization)
• Conducting a recall• Scrapping product• Cleaning product (rework procedures with an
evaluation of the adverse effects of rework)• Cleaning—a lot!
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Corrective Actions
• Changes to supplier environmental controls• Changes to raw material storage• Changes to gowning procedures• Increasing the frequency of cleaning• Changing the disinfection solution & creating a
rotating schedule• More frequent replacement of HEPA filters• Retraining
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Hairnets & Gloves
1
2
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Preventive Actions
• Most companies struggle to identify purely preventive actions• Bioburden trend analysis is an excellent source
Don’t wait until you have an excursion.
• Examples of Preventive Actions:– Monitoring raw material bioburden– Improved gowning procedures– Increasing the frequency of cleaning– Rotating disinfecting solutions– Preventive maintenance of HEPA filters
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Effectiveness Checks
• No further excursions• Re-audit of environmental monitoring• Training exams• Bioburden trend analysis
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Training
• Importance of cleanliness – “As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.” 21 CFR 820.25(b)(1)
• Personnel should be able to answer hypothetical questions about what to do if specific excursions occur
• Personnel should be able to describe and demonstrate proper gowning and cleaning procedures
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Quality Objectives
• Compliance with preventive maintenance schedules, cleaning schedules and completion of cleaning records
• Reduction in the bioburden found at various sampling points
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Q&A
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Rob Packard, Presidentwww.MedicalDeviceAcademy.com
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Need help? Contact me.
Rob Packard
+1.802.281.4381
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