Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 1 of 23

Bioburden Failure Analysis

An E. coli strain being plated for identification.

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 2 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 3 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 4 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 5 of 23

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)

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 6 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 7 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 8 of 23

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.

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 9 of 23

“Witch Hunts”

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 10 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 11 of 23

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.

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 12 of 23

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/

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 13 of 23

Root Cause AnalysisMaterials

Manpower

Mother Nature

Measurement

Machines Methods

Effect

6M’s

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 14 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 15 of 23

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!

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 16 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 17 of 23

Hairnets & Gloves

1

2

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 18 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 19 of 23

Effectiveness Checks

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 20 of 23

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

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 21 of 23

Quality Objectives

• Compliance with preventive maintenance schedules, cleaning schedules and completion of cleaning records

• Reduction in the bioburden found at various sampling points

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 22 of 23

Q&A

Rob Packard, Presidentwww.MedicalDeviceAcademy.com

rob@13485cert.com

Slide 23 of 23

Need help? Contact me.

Rob Packard

rob@13485cert.com

+1.802.281.4381

rob13485