Travel Experiences

Just a few interesting thoughts, pictures and comments about things that happen along the way – both from my personal travel and business.

Visit Nelson Laboratories at OMTEC 2014

Nelson Laboratories will be exhibiting at the OMTEC 2014 show, June 11-12, 2014, at the Donald E. Stephens Convention Burst-TestCenter (Chicago) in booth #812.

Presentation: Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them 

During the two-day conference and showcase Wendy Mach, Packaging Section Leader at Nelson Laboratories, will be presenting in the Knowledge Center on Sterile Barrier Packaging: Common Causes of Failures and How to Correct Them on Wednesday June 11th from 1:30- 3:30 pm.

This presentation will provide a brief overview of the types of tests that are available to validate a Sterile Barrier System. Though it is not expected, failures can happen while performing these tests. The presentation will take a look at common failures within these tests, provide some understanding behind why they happen, and suggest ways to correct and avoid them.

Nelson Laboratories will have technical representatives available in their booth ready to assist orthopedic device manufacturers with any questions about testing their devices and packaging.

Discussions may include:

– Validating the manufacturing residue cleanliness for orthopedic devices
– Biocompatibility testing for medical devices
– Reusable device sterilization and cleaning validations for medical devices
– Packaging validations
– Lot release testing
– And more

Don’t forget to stop by booth #812 to speak with Nelson representatives.

Location: 

Donald E. Stephens Convention Center
5555 North River Road, Chicago, IL 60018
Booth #812

ISO Meeting and Biocompatibility Standards Update, Mishima, Japan

by Thor Rollins, Biocompatibility Expert, Nelson LaboratoriesGC

I recently attended ISO (International Organization of Standardization) meetings in Mishima, Japan to participate in updating various biocompatibility testing standards. These updates are intended to reflect the best care and safety possible, regarding biocompatibility, for any given device. The updates discussed at this series of ISO meetings included the following:

  • Compound Limits: Safety limits need to be determined for each compound that can come off of a medical device during use. Currently, Ethylene Oxide (EO) gas is the only compound listed in an ISO standard that has a residual limit. However, the plasticizer diethylhexyl phthalate (DEHP), a plastic compound used in medical devices such as tubing, will likely have a limit set in the future.
  • Cytotoxicity Test: A test wherein a device, or portion of a device, is applied to living cells to see how the cells react to the materials used in the manufacture of the device. This is considered the most sensitive biocompatibility test and is a great screening tool for medical devices. The current cytotoxicity tests are qualitative; however the standard is now emphasizing the use of a quantitative version of the cytotoxicity test.   The early results from these quantitative methods have shown an increased sensitivity over the qualitative methods. A series of round robin tests are being planned to verify that the quantitative test method is consistently more sensitive.  These tests will then be followed by a discussion of clinical relevance of making the test more sensitive.
  • Different Population Limits of Chemicals: A person’s healthy limits for chemical exposure from using a medical device can vary depending on body size. For this reason, new standards for these limits are being discussed to introduce new limits according to the physical characteristics of the target population of the intended recipient. Currently, the industry standard is set for an average person weighing 70 kilograms (154 pounds), much higher than the weight of a child or infant. The new standard will consider the weights of intended populations, such as small children and infants.
  • Gas Path Devices: When using delivery systems that are intended to supply gases needed for medical purposes, compounds from those devices can come off and enter the human body. For this reason, it is necessary to standardize the effects of these compounds, in addition to the amount of compounds that will be allowed to be released during use.

Standards are reached through global consensus and serve to make the industry more efficient and effective, in addition to providing additional safety. As these standards are implemented, Nelson Laboratories will ensure the standards are met with the same quality as before.

ASTM Committee Meeting Updates for F02 and D10

Robert Haley, Packaging Department Manager, Nelson LabsMicrobial-Ranking

The American Society for Testing and Materials International (ASTM) Committee Meeting for F02 and D10 committees was recently held in Lansing, Michigan.  During the F02 meeting, there were discussions for potential round robin studies and upcoming changes to several standards. Nelson Laboratories is particularly interested in helping with the changes associated with the ASTM F88 and F1608 Standards.

Proposed changes to the ASTM F1608 – Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) – resulted in part from work performed by members of Nelson Laboratories. The changes will be highlighted during the next ASTM F02 meetings to be held in Belfast, Ireland in the fall of 2014.

The committee for ASTM F02 is seeking to perform a round-robin study for the ASTM F88 – Standard test Method for Seal Strength of Flexible Packaging Materials (Peel Test).   While participating in this study, Nelson Labs will conduct a seal peel test on rigid containers with flexible lids. Our results will be compared to the results of other labs participating in the study, to show repeatability and reproducibility of the outlined test.  The results will then be added to the precision and bias section of the standard.  The committee is currently working towards developing a standard protocol.  After the protocol has been finalized, labs to be involved in the testing should be determined.

During the D10 committee meetings, information was presented from an inter-lab study regarding the vibration section of the ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.  The current cycles are outdated due to new technology in the transportation industries.  The changes would bring the ASTM D4169 standard closer to more realistic shipping cycles.

Additionally, during the spring meetings a tour of Michigan State University (MSU) School of Packaging was arranged. The purpose of the tour was to show the facilities that MSU’s new students are exposed to when developing their education in the packaging field. These facilities are also a source of developing new technologies in the packaging field.  I would like to thank the Faculty and Students of MSU for hosting the ASTM F02 and D10 meeting.  They did a great job hosting the meeting and demonstrating the new technologies being study in the field of packaging.

ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation

Tissue testingBy Martell Winters, Senior Scientist, Nelson Laboratories

The International Organization for Standardization (ISO) hosted the Sterilization of Health Care Products Committee meeting (ISO Technical Committee 198) to update the worldwide standards used for testing and validating medical devices.

Australia was the site of this year’s meeting. I attended and served as a delegate from the United States to provide input to several documents. As part of the U.S. delegation, I contributed to discussions surrounding ISO 18362 for aseptic processing as well as ISO 11737-1 for microbiological methods.

ISO 18362 is a document detailing the minimum requirements for manufacturing cell-based health care products which are not terminally sterilized. Before attending the ISO meeting, my fellow U.S. delegates and I met to discuss and submit comments about the current document, and what we would like to see changed. We had mostly editorial comments rather than technical changes to the standard at this meeting.

This standard will help companies navigate the complexities of processing tissues and cells in a way that controls microbial contamination. Tissues and cells often cannot be sterilized by traditional means without affecting their functionality and thus are forced into an aseptic processing scenario.

This ISO 18362 document will go out for a Draft International Standard (DIS) vote. After approvals and edits, and a final vote, the new ISO standard will be implemented.

We also discussed the revision of the standard for testing and validating product bioburden—standard ISO 11737-1.  While we will likely not include any new requirements in this revision, we are adding more guidance to assist manufacturers in setting up tests and interpreting bioburden data.

For example, we are including better guidelines for determining the advantages and disadvantages to pooling multiple samples into one bioburden test when there is low contamination on a device, as opposed to using a different sample for every test.

The revision to the ISO 11737-1 standard is a result of questions we frequently receive from people unfamiliar with bioburden testing. The standard has addressed some of these questions previously but without much or any detail. A new draft of the standard should be sent out for a first review later in the year.