dsi implantable telemetry products sterility testing · testing is based on industry recognized...

DSI Implantable Telemetry Products

Sterility Testing

Updated: 19 January 2017

Peter Fritsche

____________________________________ _________________

Peter Fritsche Date

VP Quality

Data Sciences Intl. (DSI)

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The information contained within this document is confidential and privileged material intended for the sole use of the

purchasing recipient (and directly associated representatives). Any use, distribution, transmittal or re-transmittal to persons

other than the originally intended recipients may be a violation of law and is strictly prohibited.

Purpose:

Perform on-going sterility testing of representative DSI Implantable Telemetry Product samples and report results.

Each time additional sterility testing is completed, this report will be updated to incorporate the new results.

Objectives:

Generate test evidence to further substantiate DSI’s sterility claims: a) DSI Implantable Telemetry Products are sterile when stored in their original packaging for a minimum of

12 months i. Determine if this time can be extended

b) To better respond to customers if they inquire about DSI’s sterilization process c) To provide additional confidence to our customers that DSI’s products are sterile d) To proactively promote DSI’s sterilization capabilities

Background Information:

DSI uses a 3M Ethylene Oxide Steri-Vac System and medical grade packaging to sterilize our Implantable

Telemetry Products. For many years, DSI has performed an annual biological indicator sterility test to verify

proper system functionality (Appendix A).

To compliment this practice, DSI has qualified a testing protocol to check implant sterility (reference Qualification

Testing of bioMérieux, Inc. Sterility Test Media on DSI Implantable Telemetry Products December 2016).

Testing Methodology:

DSI designs and manufactures a wide variety of Implantable Telemetry Products. The factors that could influence

sterility results include: biopotential leads, catheters, chemical sensor, housing material / use of hot melt,

housing silicone dipping, housing shape / configuration, shape and size.

Sterility testing samples are representative of DSI’s Implantable Telemetry Product configurations and product

sterilization process over an extended period of years.

Testing is based on industry recognized standards (Appendix G):

Initial set of sample testing 4 implants) was performed by Diebel Laboratories (Appendix F)

USP 35 General Notices and Requirements: Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia

<71> Sterility Tests guidance o Sample sizes have been reduced o Test samples are determined based on availability o Many test samples are customer returns, so storage conditions are unknown o Packages visually appear to be intact

<1211> Sterilization and Sterility Assurance guidance

The same protocol documented in the Qualification Testing report is followed for the on-going testing (summarized in Appendix B, Appendix C)

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Tested Samples

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Test Sample Results:

Criteria after 14-day incubation period: No macroscopic evidence of microbial growth (Appendix E, Appendix G).

Test Sample Results

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Test Sample Results

Conclusion:

Using the qualified bioMérieux, Inc. Thioglycollate and Tryptic Soy Broth media, the initial representative DSI

Implantable Telemetry Product configurations and product sterilization process passed sterility testing criteria

outlined in <71> Sterility Tests guidance. Additional test samples are in-process.

If there are any future changes in the sterilization process, packaging, product materials or configurations that

would cause them to no longer be representative of this qualification testing, all or a part of this testing will be

repeated.

This report will be updated each time additional testing is completed.

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APPENDIX A

DSI’s ETO Sterilization System

and Sample Annual Biological Test Result

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APPENDIX B

Sample Handling Protocol Overview

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Sample preparation was performed in a Biosafety Cabinet (BSC). The interior of the BSC was thoroughly wiped

down with 10% bleach prior to starting.

Precautions were taken to ensure sample sterility by wearing proper equipment and following clean-room

protocol. All materials were sprayed with 10% bleach prior to placing into BSC and sterilized product was only

opened once inside BSC and any exposure time was limited.

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Containers were labeled and each implant packaging was individually opened. The implant was handled using a

sterilized forceps and upon opening the packaging, was immediately transferred to its designated media

container. The larger D-series samples would not fit in the original bioMérieux, Inc. container, so they were placed

into Falcon Sterile Sample containers, with ~175ml of media added. Exposure time of the implants and opened

media was limited as much as possible (approximately 30 – 45 seconds on average). The bioMérieux, Inc.

containers were closed tightly and the larger Falcon Sterile Sample containers were placed into a sealable bag, the

air was removed and bag was sealed.

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APPENDIX C

DSI Implantable Telemetry Sample Incubation

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Calibrated thermometers with thermocouples were used to set and monitor the two oven temperatures. The

temperature in both ovens was checked around the area where the samples would be located. The total

temperature range around the area where the samples would be located in both overs was <0.2C.

The temperature specification (Thioglycollate samples) is 32.5C +/- 2.5C. The thermocouple was positioned in

the center of the samples during the incubation period and the temperature was monitored throughout the

testing. The measured temperature range is included in the results.

Representative thermometer pictures (actual temperatures are recorded in the Incubation Temperature Record –

Appendix D):

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The temperature specification (Tryptic Soy Broth samples) is 22.5C +/- 2.5C. The thermocouple was positioned

in the center of the samples during the incubation period and the temperature was monitored throughout the

testing. The measured temperature range is included in the results.

Representative thermometer pictures (actual temperatures are recorded in the Incubation Temperature Record –

Appendix D):

Representative sample pictures:

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APPENDIX D

Incubation Temperature Record

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Incubation Temperature Record

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APPENDIX E

Post Incubation Implant Samples

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Test Sample 1 – X (Thioglycollate Medium)

Control

(no implant)

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Test Sample 1 – X (Troy Soy Broth Medium)

Control

(no implant)

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Test Sample 2 – X (Thioglycollate Medium)

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Test Sample 2 – X (Troy Soy Broth Medium)

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APPENDIX F

Diebel Laboratory Test Report

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APPENDIX G

Pertinent Sections <71> Sterility Tests guidance

<1211> Sterilization and Sterility Assurance guidance

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The information contained within this document is confidential and privileged material intended for the sole use of the purchasing recipient (and directly

associated representatives). Any use, distribution, transmittal or re-transmittal to persons other than the originally intended recipients may be a violation of

law and is strictly prohibited.

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Note: DSI is not taking samples at this level of frequency or sample size.

As samples become available, they are being tested, representing an extended

period of time. An emphasis is being placed on recently built and sterilized product.

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