May 12, 2023

Highlights from the ASTM F04 Workshop on Medical Device Cleaning Limits 2023


Committee F04 on Medical Devices sponsored a workshop on discussion setting limits for residues on medical devices during cleaning validation on May 9, 2023 in Denver, CO. The conference was organized by Stephen Spiegelberg (Cambridge Polymer Group) and Ralph Basile (Healthmark), and included presenters from testing laboratories, device manufacturers, material manufacturers, regulators, toxicologists, and cleaning consultants.

Randy Thoma (Veeasquared) presented a historical perspective on the Sulzer Interop recall in the early 2000s, which prompted the formation of the cleaning task group in ASTM. Jeff Rufner and Ben Grosjean (Zimmer) discussed how to leverage residues in clinically-successful devices in establishing acceptance limits. Allan Kimble (J&J) focused his talk on test methods and their suitability towards patient safety. 

Becky Bader (Cambridge Polymer Group) presented a summary of standards related to particulate levels and measurement techniques and gaps in this standardization. A presentation by Daniel Curtin (Edwards Lifesciences) focused on designing a cleaning validation approach for multi-component cleaning processes. Boopathy Dhanapal presented the current information on ISO standards related to cleaning and levels. Clement Cremmel (Ultraschall) described ultrasonic cleaning and examples of establishing limits in cleaning metallic devices. Reto Luginbuehl (Blaser) described chemical deformation of lubricants and the use of toxicology data to determine limits. Barbara and Ed Kanegsberg (BFK) talked about cleaning standards. 

In the afternoon, Isaac Mohar (Gradient) discussed how toxicology is used to establish limits, which was continued in the next talk by Robert Mueller (Nelson Labs), who presented on the use of ISO 10993-18/17 for establishing limits. Terra Kremer (J&J) led a discussion on the using of the Spaulding classification system to establish limits for re-usable devices. The discussion of re-usables continued with a talk about cleaning dental products by Spiro Megremis (ADA Science and Research Institute), and a study of test soils for cleaning validation by Stephen Morris (Stryker).

The day finished with a talk by Terry Woods (FDA) on the FDA’s use and reliance on standards, followed by a group discussion of gaps in standards and the need for additional standards related to setting limits. This work will be conducted within task group F04.15.17.

CPG consults with clients on a regular basis in cleaning assessment and validationContact us for more information on how we can help you.

Posted by CatherineCerasuolo
May 2, 2023

New Ethylene Oxide Sterilization Standards Proposed


The Environmental Protection Agency (EPA) is proposing new standards on chemicals used to sterilize medical devices, including ethylene oxide (EO/EtO), one of the more commonly used sterilants. However, ethylene oxide has recently been scrutinized due to safety concerns about workers' EtO exposure at sterilization facilities.

The EPA is proposing a decrease in the highest allowable airborne concentration of ethylene oxide. The proposed level of EtO is 0.2 parts per million (ppm), which is lower than the current standard of 1 ppm.

This proposed standard is based on recent research that suggests that long-term exposure to an amount of EtO greater than 0.2 ppm can be hazardous to human health. The EPA also proposes that sterilization facilities must implement rigorous monitoring and reporting protocols to ensure the safety of workers and surrounding communities.

Although ethylene oxide is a toxic gas, it is an effective sterilant for many medical devices that cannot be sterilized by ionizing radiation (gamma, e-beam, or X-ray) or through steam autoclaves, due to the polymer composition of these devices.

Some trade associations are concerned about the EPA's proposal. They believe the safety requirements will take longer than 18 months to put into place. A slowdown of EtO sterilization could affect the supply chain of billions of medical devices per year, negatively impacting patients' access to health care.

Consider Alternative Sterilization Modalities

This slowdown may push device manufacturers to consider other sterilization modalities. CPG has expertise in radiation chemistry of polymers, as well as how temperature can affect these materials, and can assist clients in developing and validating appropriate sterilization processes for medical devices.

Medical device manufacturers who make changes in their sterilization method, process or facility outlined in their original Premarket Approval must submit a PMA supplement so that the FDA can review the changes. 510(k) holders would need to consult FDA guidance on whether a change in sterilization modality on their device would require a new 510(k) submission.

CPG's team of materials experts can explain the complexities of the sterilization process and provide guidance on the best options to meet regulatory requirements. We can help clients evaluate sterilization modalities, and if a change in the sterilization method is required, we can provide support in filing the appropriate PMA supplement or 510(k).

Our polymer scientists can provide answers to any questions you may have and offer a comprehensive plan to ensure your medical device is compliant with FDA requirements. Contact one of our scientists today for a consultation.

Posted by CatherineCerasuolo
March 13, 2023

Registration Open for ASTM F04 Workshop on Cleaning Medical Devices


Registration is open for ASTM International’s Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices, to be held May 9, 2023 at the Sheraton Denver Downtown Hotel (Denver, Colorado, USA). The event is sponsored by ASTM’s medical and surgical materials and devices committee (F04) and will be held in conjunction with the May standards development meetings of the committee.

This workshop will identify current best practices in setting acceptance limits in cleaning of medical devices, gaps in standardization of this practice, and areas where new standards would be useful. Considerations include crossover with ISO 10993 standards and potential updates to these requirements.

Topics include, but are not limited to:

  • Case studies of cleaning with issues associated with acceptance limits;
  • Current standards on cleaning of medical devices;
  • Types of residues and considerations;
  • Methods for establishing acceptance limits;
  • Approaches for using acceptance limits in cleaning validation;
  • When to modify acceptance limits;
  • Approaches to limit establishment when there is a change in manufacturing process;
  • Gaps in acceptance limits guidance;
  • Pharmaceutical manufacturer position on acceptance limits;
  • Regulatory perspective on setting limits and rationale; and
  • Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices.

Additional information is available from the workshop’s technical chairs, Stephen Spiegelberg ( and Ralph Basile (

To register for the event or for more information, visit

Symposia Operations Contact: Tammy Schane, tel+1.610.832.9522,

Posted by CatherineCerasuolo
January 28, 2023

O thou, my muse! guid auld Scotch drink!


At the end of January, Scots and poetry lovers around the world gather to celebrate the birthday of Scotland’s most famous poet, Robert (or Rabbie) Burns. Burns Night guests sit at long tables sipping Scotch while the haggis is paraded about the room, followed by a bagpiper playing musical tribute to Scotland’s traditional Haggis. Burns’ “Address to a Haggis” is recited and then the pudding is served.  For those less adventurous there are even excellent vegetarian options available!

An integral part of the celebration is the liberal application of whisky.  For many people, this is more important than the poetry!  Whisky is Scotland’s official national drink (though IRN BRU may beg to differ), and Burns’ poetry is filled with whisky references. In “Scotch Drink,” Burns credits whisky as his muse and inspiration.  In “Tam o’ Shanter,” he says that the “water of life” inspires devil-facing powers, and in “The Author’s Earnest Cry and Prayer,” he equates freedom with whisky.

As our own tribute to Burns’ self-proclaimed inspiration, Cambridge Polymer Group performed some chromatographic analysis on a number of single malt Scotches from the Highlands, Arran, Islay and Speyside.

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Although there are few discernable patterns in the Gas Chromatography data, some qualitative trends are observed. Furfural, Hexanoic acid and 1-Butanol are largely present in all samples. The p-Cresol appears more associated with the Spey whiskies, and the o-Cresol appears more associated with the Islay whiskies. In terms of the three different aged whiskies (-15, -16 and -17, from Arran), there is no compound that appears to rank with age. Reviewing the Head Space Gas Chromatography data, the compounds that one would expect to provide the closest match to the drinker’s initial perception of the whisky yields a similar result, with no clear pattern emerging.

Our initial hope of teasing out simple correlations with known traits of the whiskies was not borne out.  At least partially this is due to the intrinsic complexity of these liquids, with combinations of age, processing, environment and ingredients resulting in a complexity that is difficult to handle analytically.  In addition, most of the liquids presented here are in fact blended from multiple barrels (even though they are termed “single malts”) to create a certain profile, further complicating any analytical process. 

This study was an internal project, conducted to demonstrate some of CPG’s chromatographic abilities without compromising any confidential client data and as an excuse to hold a whisky tasting with leftover supplies. When CPG analyzes a product on behalf of a client, we have access to the manufacturer’s IP (including key information about processing, environment, and materials), which allows us to better isolate compound correlations with known traits.

Complexity is increasingly becoming the norm in analytical chemistry. CPG conducts complex profiles in Extractable and Leachable (E&L) studies in support of biocompatibility determinations, and for new medical devices and drugs requiring analysis in vivo for residual products or change products. However, because we keep our clients’ IP confidential, we can’t share most of those examples (unless our client has given permission or credited us in publication).  CPG is very proud of our part in a cancer study, in which we performed a complex direct analysis of physiological fluids for analytes generated by the body (which we can discuss because our participation was published by our client). 

Although the hoped-for patterns were not found in this small sampling, gas chromatography has potential value across a range of fields and understanding how to apply and tailor analysis to specific applications will become more important in the future. Plus, unlike usual laboratory experiments, it was encouraged to taste these samples.

So today, join the revelers world-wide, celebrating Burns Night on the weekend following his birthday, and raise a dram of furfural/hexanoic acid/1-butanol to one of the world's greatest poets!

Posted by CatherineCerasuolo
December 28, 2022

ASTM F04 Cleaning Validation Workshop - Call for Presentations

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May 9, 2023 - Setting Acceptance Limits for Cleaning Validation of Medical Devices

Sheraton Denver Downtown, Denver, CO, USA. For general information about the workshop, please visit the event website.


Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices, the workshop will be held in conjunction with the May standards development meetings of the committee.

This workshop will identify current best practices in setting acceptance limits in cleaning of medical devices, gaps in standardization of this practice, and areas where new standards would be useful. Considerations include crossover with ISO 10993 standards and potential updates to these requirements.

Workshop Topics

Topics include, but are not limited to:

    • Case studies of cleaning with issues associated with acceptance limits
    • Current standards on cleaning of medical devices
    • Types of residues and considerations
      • Include manufacturing residues, particles, environmental agents, cleaning agents
      • Exogenous factors
      • Knowing what your manufacturing materials are composed of
    • Methods for establishing acceptance limits
      • Historical clinical history
      • Toxicological risk assessment
      • Cytotoxicity
      • Patient risk assessment
    • Approaches for using acceptance limits in cleaning validation
      • How cleaning affects sterilization
      • How cleaning affects biocompatibility
      • Consistency of cleaning process
      • Impact of cleaning on device functionality or user experience
      • Risk assessment in using acceptance limits
    • When to modify acceptance limits
    • Approaches to limit establishment when there is a change in manufacturing process
    • What are the gaps in acceptance limits guidance?
    • The pharmaceutical manufacturer position on acceptance limits
    • Regulatory perspective on setting limits and rationale
    • Development of proposal(s) for development of new ASTM standards related to acceptance limits for medical devices


Abstract Submission

Please submit your 300-word abstract pertaining to the topics above to Workshop Co-Chairs Stephen Spiegelberg at and Ralph Basile at by close of business January 20, 2023.

Posted by CatherineCerasuolo
December 19, 2022

All Aboard The Polar Ion Express

On the night before the holidays, not so long ago, a Cambridge Polymer Group research scientist bustled about his lab bench. None of his projects were overdue, but he had decided to stay late to catch a glimpse of Nicholas Flamel. His coworker had begged him to go home and relax. “There is no such thing as Nicholas Flamel. He’s just an old alchemist myth hyped by Harry Potter,” the coworker had insisted.


But the Cambridge Polymer scientist knew his coworker was wrong; she was only recently hired and hadn’t seen the security footage from when Nicholas and his reindeer had visited the CPG lab in 2019. As he worked in silence, he listened for the ringing bells of Alchemist Nick’s sleigh.

Late that night, the CPG scientist did hear sounds, though not of bells. From outside came the ear-splitting sounds of wheel squeal. He flung open the back door and saw a train parked in the loading dock, surrounded by a cloud of vapor. An engineer (who was both the train driver AND a PhD in applied science) popped his head out of the engine’s window. Before the engineer could say, “All aboard the Polar Ion Express,” the research scientist leapt onto the train.

The car was filled with other scientists, all in their lab coats and PPE, singing songs including Tom Lehrer’s "The Elements” (updated to cover elements discovered after 1959) and They Might Be Giants’ “Science Is Real.” Silly putty bounced off the walls, and paper airplanes whizzed past ears. Robots wheeled around with trays of freeze-dried astronaut ice cream and rock candy.

His coworker ran up to him, “They picked me up at home!!! Is this for real???”

The two CPG staff explored the rest of the train. There was a car where passengers could safely play with the world’s most dangerous toys.  Austin Magic Pistols, which shot ping pong AND fire balls, Clackers, unintentionally explosive polymer balls modeled after Argentinean bolas, and 1950s radioactive atomic energy lab kits could all be used without fear of injury to self or others thanks to full body Kevlar and shielding on the car’s exterior.

iStock-1339594028.jpgIn the padded anti-gravity car, passengers floated about, chasing their choice of cold beverage, droplet by suspended droplet. Scientists who were more than thirsty stopped at the Molecular Gastronomy car, where they enjoyed culinary concoctions of carefully engineered flavor, reminiscent of Willy Wonka.

The Non-Newtonian Fluids car featured a jello trampoline, a Build-Your-Own-Oobleck-Stress-Ball table, and the chance to get swallowed in quicksand (only up to the neck and then pulled out). Anyone overheard using scientific terminology incorrectly would be slimed with a thick green ooze, dumped by a ceiling robot.

There was a car with sensory deprivation tanks; bathers reported a 99.9% rate of Eureka moments. The tanks were also helpful in rinsing off the colloids from the previous car.

The Polar Ion Express traveled past lonely studio apartments and jail cells, where former scientists and entrepreneurs who had faked their data howled at their loss of integrity and inability to board the train.


As the Express approached the lower polar region, passengers flocked to an observation car to watch the green and blue auroras that formed when electrons and ions collided with atoms of oxygen and nitrogen in the upper atmosphere.

Finally, the train reached its destination. “There,” said the engineer, “is Nicholas Flamel’s laboratory.”

Alchemist Nick’s laboratory was a huge complex standing alone at the top of the world. There were rumors of a telomere department in an underground bunker, but Flamel carefully guarded his anti-aging IP until he could be certain his discoveries would be used ethically. Instead of divulging secrets that could destroy the Earth’s already stressed carrying capacity, he used the fortune he had amassed through hundreds of years of compound interest to fund ground-breaking research and supply worthy scientists with the tools they need to improve quality of life.

Nicholas Flamel greeted the passengers, standing next to his reindeer and the bell-covered sleigh. He was surrounded by all the analytical instruments a material scientist could ever want, including QTOFs, TOFs, LCs, GCs, Mass Spectrometers, GPCs, Scanning Electron Microscopes, Digital Microscopes, Rheometers, Viscometers, DSCs, TGAs, Melt Flow Index Testers, DMAs, FTIRs, Tensile Testers, Swell Ratio Testers, and CaBERs.

Now that the CPG scientist was close enough to see the bells, he realized they were miniature copies of the Oxford Electric Bell. Otherwise known as the Clarendon Dry Pile, the original has been ringing for 182 years and has been called the “world’s most durable battery.” No one knows how or why it has functioned for so long. No one, that is, except for Nicholas Flamel.


The CPG scientist said, “That sound of those bells is the most beautiful I have ever heard.”

“Flamel slays,” his Gen Z coworker declared, shaking her head in awed agreement, though she was clearly more impressed by the analytical instruments surrounding the sleigh, rather than the musical instruments adorning it.

Nicholas strode over to the CPG research scientist, “Now what would you like?”

The CPG scientist looked at the dizzying array of state-of-the-art instrumentation. “Cambridge Polymer Group already has those instruments,” he thought to himself, “and it’s not like I have a Batcave at home.”

“I’d like one of your bells,” the CPG scientist said out loud.

Nicholas smiled and told a robot to remove a bell apparatus from the sleigh. He held it up, “The first gift!”

The crowd cheered as the CPG research scientist took the bell and put it carefully in his pocket.

On the train ride back, the research scientist suddenly noticed that the bell was gone. He sadly showed his coworker, wiggling his fingers through the hole in his lab coat pocket. She dragged him back to the Non-Newtonian Fluids car, where the joy of jumping in jello soon made him forget his loss.

The next morning, his coworker called and asked if Alchemist Nick had left the bell under the CPG research scientist’s Chemist-Tree.  

“No, but it’s OK,” he said, a sudden realization dawning on him, “I’ve always wanted to win a No Bell Prize!”

Cambridge Polymer Group wishes you a holiday filled with real magic (a.k.a. science)!

CPG Holiday Hours

In observance of the holidays, Cambridge Polymer Group will be closed:

Friday, December 23

Monday, December 26

Friday, December 30

Monday, January 2

We will resume regular business hours on Tuesday, January 3.

Posted by CatherineCerasuolo
November 16, 2022

What is That Residue?

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Attending PharmaEd Resources Cleaning Validation Summit in San Diego in December? Don't miss CPG President Stephen Spiegelberg's talk on December 1 at 3:35 p.m. "What Is That Residue? When Visual Assessment and TOC Is Not Enough in Cleaning Testing."

Cleaning Operations Root Cause Analysis

Cleaning validation activities often involve nonspecific qualitative and quantitative assessment of residues using total organic carbon, weighing of residue, and visual assessment. In most cases, these levels of analysis are sufficient to establish consistency in cleaning operations. When cleaning operations drift out of control, or a downstream failure occurs, specificity in residue identification and quantitation is sometimes needed to determine the source of the issue. In this presentation, case studies of cleaning operations that required additional analysis are presented, with analytical techniques selected to help identify issues with cleaning operations as part of a root cause investigation.

Cleaning Validation Summit 2022, San Diego

Today’s regulators expect comprehensive risk assessments of your organization’s cleaning validation protocols. Attend Pharma Ed’s Cleaning Validation Summit at the Marriott San Diego Mission Valley on Dec 1-2 to learn best practices from leading industry experts and help you meet regulatory requirements. 


Posted by CatherineCerasuolo