Cambridge Polymer Group

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.

November 14, 2022

Stephen Spiegelberg Receives ASTM International’s Top Annual Award

ASTM International presented its top annual award – the Award of Merit – to Dr. Stephen Spiegelberg for his contributions to ASTM’s F04 Committee on Medical and Surgical Materials and Devices (F04).

The prestigious award, which includes the accompanying title of fellow, is ASTM’s highest recognition for distinguished service and outstanding participation in ASTM International committee activities. Spiegelberg was recognized for his highly adept, collaborative work in developing cleanliness standards and for his pioneering leadership in the field of medical device cleanliness assessment. Committee F04 also cites his skilled oversight of development, even during contentious discussions.

Spiegelberg said, "I am honored to receive this award and excited to be back to in-person ASTM meetings."

An ASTM International member since 1998, Spiegelberg had been previously honored by the committee with two Awards of Appreciation (2001, 2011), the Robert E. Fairer Award (2004), the Leroy Wyman Award (2012), and the Patrick G. Laing Award (2018).

Spiegelberg serves as president of Cambridge Polymer Group, Inc., which he co-founded in 1996. Cambridge Polymer Group provides consultation and testing in biomedical product and material development. Spiegelberg received his Bachelor of Science in chemical engineering from the University of Wisconsin-Madison in 1988. Spiegelberg also earned a Ph.D. in chemical engineering from Massachusetts Institute of Technology (MIT) in 1993, with a focus on polymers and fracture mechanics.

About ASTM International

Committed to serving global societal needs, ASTM International positively impacts public health and safety, consumer confidence, and overall quality of life. ASTM integrates consensus standards – developed with an international membership of volunteer technical experts – and innovates services to improve lives… Helping our world work better.

May 9, 2022

Material Selection for Physical Product Development

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Material selection plays an essential role in the success or failure of your product. Materials experts (including CPG President Stephen Spiegelberg) discuss strategies for choosing the best material for your product's application. The panel will cover: medical device considerations, biomaterials and composites, molded parts and consumer products, subsystem connections, harsh environment considerations, additive manufacturing use cases and more. Don't miss this opportunity for free medical device and product development advice (not to mention free pizza).

Date

Tuesday, May 17, 4:30 -6:30 p.m.

Location

Innovation Hub at UML. 110 Canal Street, 3rd floor. Lowell, MA 01853

Parking

Canal Street is open all the way through to a new parking lot and HCID garage behind #110 (and new #201 Canal apartments). Meters run in 2 hour blocks until 6 p.m.

Food

Vegetarian and non-vegetarian pizza and soda

Register

December 17, 2021

How the Leachable Stole LCMS

Front of card2.jpg All the staff at Cambridge Polymer liked Chromatography a lot…
But the Leachable, living in the 10993 aliquot, did NOT!
The Leach hated Chromatography and all of CPG with a passion!
Now please don’t ask us why. We really can’t imagine.

It could be that his vial cap was screwed on too tight.
It could be his polymer network wasn’t cured just right.
But we think the most likely of all reasons compiled
Was the Leach did not want to be analytically profiled.
But, whatever the reason, his cap or his cure,
He lurked in his vial, hostile and insecure.

Staring down from the fume hood, with a sour, Leachy frown
At the vials in the autosampler spinning around.
He growled with amorphous ends oozingly drumming,
“I must find some way to keep this ISO 10993 study from running!
Why, through exhaustive extractions I’ve put up with it now!
I MUST stop this chemical characterization from finishing! But HOW?”

“For, tomorrow, I know the 10993-18 team
Will arrive bright and early and they'll rush for the LCMS machine!”
Then he thought of a plan quite clever but mean.
"I know just what to do!" The Leach laughed in glee at his scheme.

Once the lab went dark and all CPG staff left,
He slunk to the LCMS bay to begin his theft.
Through all the bay’s cabinets, he took every supply:
Caps, columns, clamping rings, filters, and reagents!
Pipettes, reference standards, septa and solvents!
And he stuffed them in bags. Then the Leach, very smart,
Stuffed all the bags, one by one, onto the lab cart.

"Now," grinned the Leach, flexing his pecs, "I will steal the LCMS!"
He oozed over to the instrument, sure of success,
But despite the strength of his loathing, the machine wouldn’t budge.
“I will unplug all the cords and tubes instead,” growled the Leach with a grudge.
He slapped an “Instrument Out of Service” form on the LCMS for good measure.
Then he started to push the cart with his chromatographic treasure.

But Leaches are small, the old Leachable found
And it takes them quite a long time to cover any lab ground.
What to the Leach seemed like miles, sore and decrepit,
He pushed his pile towards the loading dock to scrap it.
By the time he reached the loading dock door, the sun had risen
The lab lights turned on and the Leachable paused to listen.

“They’re finding out now no 10993 study is running!
They’re just getting in! I know just what they’ll do!
Their eyes will pop out a minute or two
Then they’ll call the LCMS service vendor and cry BOO-HOO!”
And he did hear a sound from that part of the lab.
But this sound wasn’t bawling or frantic beserking.
Why, this sound sounded like instruments working!

The Leach couldn’t see what was happening
But he heard the word “QTOF,” which he found quite baffling.
He HADN’T stopped 10993-18 from running! IT RAN!
Somehow or other, without the second bay’s LCMS,
It ran nonetheless!

“Maybe 10993-18,” he thought, “Isn’t dependent on a single chromatography machine.
Maybe 10993-18…perhaps…is more than just a toxicology screen!”
Then he heard the scientists discussing elution of antibiotic
And the Leach was filled with relief on a level atomic
Why, he wasn’t toxic, he was a desired migration
The Leach was part of a drug delivery formulation
He didn’t poison people, he made infections stoppable.
After this revelation, the Leach felt a little less volatile.
He left the cart for a confused Receiving admin to find,
And started the trek back to his vial, with new peace of mind.

Wishing you peace and prosperity in 2022

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September 30, 2021

CPG Exhibits at Mass Manufacturing Mash-Up

Research Scientist Veronica Holmes at CPG's table at the Massachusetts Manufacturing Mash-Up.

Cambridge Polymer Group is proud to have been an exhibitor at the first ever Massachusetts Manufacturing Mash-Up held on Tuesday, September 28, at Polar Park in Worcester, MA. The event attracted over 30 exhibitors and 600 attendees, including manufacturers, suppliers, academics and jobseekers.

Massachusetts offers a unique environment for manufacturing innovation. As the location of some of the world’s best universities, Massachusetts benefits both from the cutting-edge research conducted at these institutions as well as the talented graduates who often remain in state and start their own companies. Perhaps this high-caliber talent pool is why Massachusetts ranks third in the US for venture capital investment. The Mash-Up, organized by the Center for Advanced Manufacturing at MassTech (CAM), MassMEP, MassRobotics, FORGE, WPI, and MassHire, was designed to foster greater connections between these area resources of academia, business, and skilled workforce to solve industry challenges.

CPG helps manufacturers and startups by developing solutions to their materials problems, at all stages of their product development, production and distribution cycles. Our contract research experts determine what analysis or development a manufacturer requires. Working with CPG provides manufacturers with access to state-of-the-art instrumentation, skilled equipment operators, and materials experts who translate test results into solutions. Buying specialized equipment and hiring the staff for short-term research needs is prohibitively expensive for many manufacturers. CPG provides manufacturers with analysis or development that optimizes product and accelerates success.

CPG appreciated this opportunity to connect with our local manufacturing community in 2021, and we look forward to next year’s event!

July 7, 2021

Forger Caught by Rheology of Biopolymer Gum Arabic

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Gum arabic, a sap harvested from acacia trees, is a very useful biopolymer due to its physical and chemical properties.

The forgeries and murders committed by Mark Hofmann in the 1980s have been dragged back into the cultural spotlight by a recent Netflix/BBC documentary. [1] Hofmann counterfeited an amazing breadth of documents supposedly written by American historical and literary figures such as George Washington, John Adams, John Quincy Adams, Daniel Boone, John Brown, Andrew Jackson, Mark Twain, Nathan Hale, John Hancock, Francis Scott Key, Abraham Lincoln, Emily Dickinson, Paul Revere, Myles Standish, and founding members of the LDS church. Hofmann’s forgeries fooled both the Library of Congress and the FBI, but eventually one of Mark’s associates began to suspect the authenticity of Mark’s finds.

When it became obvious to Hofmann that his extensive forgery scheme was about to be exposed, he killed two people with pipe bombs in an attempt to hide his guilt. He then detonated a third bomb in his own car and appeared to be just another victim of a serial killer targeting document dealers. Public sympathy for Hofmann began to turn to suspicion when an eyewitness placed him at the scene of the first murder. Police raided Hofmann’s home but did not find what they considered to be proof of criminal activity. In reality, Hofmann’s house was filled with incriminating evidence, but it took the untiring efforts of two document examiners to look at that evidence in the right way, i.e., under a microscope.

Catch You Later Alligator

Despite an FBI lab’s determination that Hofmann’s documents were authentic, George Throckmorton, the document expert for Utah’s attorney general, and William Flynn, an Arizona document examiner, were skeptical of Hofmann’s “finds.” In most cases, previous authentication testing was limited to determining the age of the paper and/or ruling out the use of multiple inks. Because a forger may use a single ink and paper stolen from the blank pages of old books, Throckmorton and Flynn did not view the results of previous testing as conclusive.

After inspecting numerous documents “found” by Hoffman under the microscope, Throckmorton noticed that the iron gallotannic ink was cracked. Throckmorton and Flynn were then able to confirm that all Hofmann documents contained the cracked ink, while genuine documents, also written with iron gallotannic ink but proven to be untouched by Hofmann, did not contain the “alligator” pattern. [2]

Next, the dynamic document duo set out to demonstrate why the alligator patterned ink on Hoffman-handled documents was proof of forgery, and therefore a viable motive for murder.

Accelerated Aging

Flynn suspected that whatever method Hofmann used to make the document appear older had also cracked the ink. He treated iron gallotannic ink with sodium hydroxide, a common household product, and found that it was excellent at rapidly converting the iron in the ink to rust, reducing a process that usually takes years into days. However, even though the ink turned from black to a convincing deep brown with reddish tones, Flynn was not able to see the alligator cracks under the microscope.

After conferring with Throckmorton, Flynn decided that his ink formulation might be different than Hofmann’s. He remembered seeing Great Forgers and Famous Fakes by Charles Hamilton in the property seized from Hofmann by police. Upon checking the book, Flynn stumbled upon a recipe for 19th century iron gallotannic ink that contained gum arabic, which was not present in Flynn’s first ink formulation. [3]

Gum arabic (GA), the edible, hardened sap of acacia trees (Acacia senegal and Acacia seyal), is a hydrocolloid with an extensive list of accomplishments. Stone Age Sibudu Cave inhabitants used it to form the first super glue (a mixture of gum arabic and pigment that required heating at a specific temperature range, achieved by distance from the fire and wood selection). [4] Ancient Egyptians adhered mummy wrappings and mixed cosmetics and hieroglyph paints with it.

In modern times, the biopolymer has continued to play a key role in art as a binder in paints, ceramic glazes, photography, and fireworks. GA is also a pervasive food and beverage additive, used as a stabilizer, emulsifier, thickening agent, binder and mouthfeel enhancer. Pharmaceutical applications include drug delivery and treatment of stomach inflammation. CPG appreciates gum arabic as a reagent for volatile hydrocarbons testing in ASTM D460-91, and as an ingredient in one of our favorite Valentine treats, candy hearts. But how did this ancient and incredibly useful material lead to the capture of the psychotic forger?

Flynn synthesized Hamilton’s ink formula using gum arabic, penned his test script, then applied sodium hydroxide to the writing. When he put his sample under the microscope, Flynn did indeed find alligator patterned cracking. Exposure to sodium hydroxide causes a chemical change in the gum arabic, likely through the hydrolysis of the proteinaceous component of the gum arabic; the gum shifts from a thin fluid to a brittle material, hence the observed cracking.

The material evidence discovered by Throckmorton and Flynn was enough to convince the police that they now had motive. This perspective on the case opened many new fruitful areas of inquiry. Hofmann was the culprit, given away by gum arabic. Although he was trying to recreate the original 19th century ink formulation by using the biopolymer, he would have likely remained undetected if he had omitted the telltale ingredient.

Later during a confession in open court, Hofmann shared more details of his forgery techniques. He had constructed an ozone chamber out of a five-gallon fish tank, a piece of glass, some wire, and a jar filled with water and salt, and used it to simulate environmental damage to his forged documents. Hofmann also employed a vacuum to suck ink to the back side of a document to mimic seepage that usually occurs over the course of hundreds of years.

What Would CPG Do?

Integrity is one of CPG’s core values and we certainly do not perform accelerated aging for the purposes of forgery. We do provide both ASTM and customized accelerated aging to predict a material’s behavior over time, usually for medical device and industrial applications. Depending on your real-world applications, adjustments to standard testing are often necessary, and we have experience creating custom environments to mimic your product’s in-use conditions.

CPG was founded in 1996, so we were not around to help document gumshoes Throckmorton and Flynn find their telltale gum. However, we have extensive experience in ink and paint analysis for manufacturers, including product deformulation and failure analysis. Contact CPG for your paints and coatings testing, R&D and product development needs.

[1] Murder Among the Mormons. Directed by Jared Hess and Tyler Measom. BBC Productions, 2021. Netflix, https://www.netflix.com/title/81226889

[2] “How Two Document Examiners Solved the Case of the Salamander Letter.” Western Forensic Document Examiner, 12/05/2019. https://www.westernforensicdocumentexaminer.com/document-examiners-solved-salamander-letter-case/

[3] Jones, Robert A., “The White Salamander Murders: Mark Hofmann’s Discoveries Had Shaken the Mormon Church.: Then a Bomb Went Off. And Then Another.” Los Angeles Times, April 5, 1987. https://www.latimes.com/archives/la-xpm-1987-04-05-tm-3-story.html

[4] Keim, Brandon, “Stone Age superglue: a first sign of intelligence?” Wired, May 13, 2009. https://www.wired.co.uk/article/stone-age-superglue-a-first-sign-of-intelligence

June 14, 2021

CPG’s Boston Office Is Relocating to Woburn in August 2021

Cambridge Polymer Group, a premier contract R&D lab supporting medical device, pharmaceutical, consumer products and industrial companies, is moving to a new 17,000 SF facility on August 5, 2021. After two decades in Boston’s Charlestown neighborhood, CPG is relocating to Cummings Properties’ TradeCenter 128 campus in Woburn to accommodate rapid growth.

Conveniently situated on Route 128/I-95 on the Burlington/Woburn line, the new facility was chosen to fulfill Cambridge Polymer Group’s requirement for a large, customizable, highly technical space. The 117% increase in custom-built lab space will allow us to meet the growing demand for our varied, specialized analytical testing and research & development services. The additional capacity accommodates the ongoing expansion of our product development, chromatography, and extractables & leachables departments.

Since the Woburn site is only 12 miles north of our Charlestown location, CPG will be retaining existing staff. The 11% increase in office space provides room for a welcoming reception area, a spacious conference room, and more cubicles and offices, allowing for the acquisition of additional team members. Our new location offers plenty of free parking for both employees and visitors.

As an ISO 9001:2015 certified and ISO 17025:2017 accredited (Cert # 3930.01) testing laboratory, CPG takes quality very seriously. We are implementing a carefully planned phase approach to the relocation, designed to ensure a smooth transition. Our plan minimizes workflow disruptions and meticulously maintains the integrity of project research and instrument calibration.

NEW CAMBRIDGE POLYMER GROUP ADDRESS

Cambridge Polymer Group, Inc.
100 TradeCenter Drive, Suite 200
Woburn, MA 01801

Our contact numbers will remain the same, including our main number: 617-629-4400.

FOR CLIENTS

As of July 30, 2021, we will no longer be able to accept samples at 56 Roland Street, Suite 310, Boston, MA 02129. A sample submission form with our new location details is posted on our website and linked in our email signature.

For RFQs, sample submission questions, and PO submissions, please contact CPGsales@campoly.com or call 617-629-4400, ext. 2.

If you would like to see Cambridge Polymer Group’s new space and meet our team of PhD problem solvers, please email info@campoly.com to schedule a visit.

FOR VENDORS

Shipments should be delivered to our dedicated loading dock. For questions about deliveries, contact Receiving at receiving@campoly.com or 617-629-4400, ext. 21.

For Accounts Payable inquiries, please contact payables@campoly.com or 617-629-4400, ext. 3. 

We look forward to continuing to work with you at our new address. 

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