Rob Packard, President [email protected] Slide 1 of 23 Bioburden Failure Analysis An E. coli strain...

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

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Bioburden Failure Analysis

An E. coli strain being plated for identification.

http://www.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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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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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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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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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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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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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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“Witch Hunts”

• Request copies of documents and records in parallel with requesting a supplier corrective action (SCAR)




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SCAR Effectiveness Checkhttp://www.medicaldeviceacademy.com/supplier-auditing-tool-kit



http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit


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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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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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Root Cause AnalysisMaterials

Manpower

Mother Nature

Measurement

Machines Methods

Effect

6M’s




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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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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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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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Hairnets & Gloves

1

2




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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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Effectiveness Checks

• No further excursions• Re-audit of environmental monitoring• Training exams• Bioburden trend analysis




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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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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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Q&A




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Need help? Contact me.

Rob Packard

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+1.802.281.4381

rob13485



Rob Packard, President [email protected] Slide 1 of 23 Bioburden Failure Analysis An E. coli strain...

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