ELEMENT LAUNCHES EXTRACTABLES AND LEACHABLES SERVICE

https://www.guardtechgroup.com/

Guardtech offers decontamination package

The Guardtech Group is providing a package of decontamination services –either as part of a Cleanroom Service Plan or scheduled separately two leaders of the team with 30 years’ experience in decontamination.

The Decon Team works to GMP standards and specializes in restoring control to critical environments, offering cleaning programs and multi-stage cleaning as and when required.

The company claims the team can conduct full microbiological/bioburden testing with TSA & SDA plates and preclean and post-clean contact plate testing, as well as cleanliness verification tests with full reporting.

Guardtech provide a hydrogen peroxide fogging service, either as part of their Cleanroom Service Plan or a Decon-only Program.

Element Materials Technology (Element) has launched a global offering for its Extractables and Leachables (E&L) services.

The new service brings together capabilities across Europe and North America through the recent acquisitions of Avomeen, Hall Analytical and VR Analytical totaling over 75 experts across laboratories in Ann Arbour and Bend in the US, Toronto in Canada and Manchester in the UK.

Regulatory agencies are requiring more and increasingly complex E&L studies before drugs and products come to market. The impact of extractable and leachable substances on product safety and drug product interaction is now studied and evaluated throughout the drug development process to make sure certain drug efficacy and patient safety are not compromised.

Sarah Brophy, global scientific director for extractables and leachables, life sciences, Element, said: “Our combined knowledge and experience helps us deliver an unequalled expertise in the rigorous testing for E&L on a whole range of products across the world’s regulatory authorities. Keeping up with ever increasing demands for product testing and delivery is a significant part of the approval process.”

Guardtech’s operatives follow client SOPs and use specific validated chemicals and equipment when required, with the

Company Update

https://www.microcare.com/

MicroCare announces the hiring of senior quality control chemist

MicroCare has announced the hiring of Rebecca Mahoney as senior quality control chemist. Mahoney brings over 12 years of experience in the pharmaceutical and industrial biotechnology industries, where she conducted analytical techniques to support product development.

As senior quality control chemist, Mahoney will be responsible for developing, conducting, and overseeing analytical methods to test incoming raw materials and approve outgoing MicroCare products.

The Decon Team utilizes EndoSan SHP dry misting technology – and say it’s proven to achieve greater than log 5 reduction (99.999%) in bacteria and at least a log 3 (99.9%) reduction in virus of the coronavirus family.

“Rebecca’s extensive experience and skill in analytical methods, development and validation will undoubtedly make a great contribution to the continued success of our organization. We are excited to add her to the MicroCare team,” said Marufur Rahim, technical laboratory director at MicroCare.

Before coming to MicroCare, Mahoney held analytical chemist and quality assurance chemist roles at Pfizer, Thor Specialties and most recently, Invicro.

“I am thrilled to be joining MicroCare, a company that is at the forefront of innovation in the critical cleaning industry,” said Mahoney. “I look forward to using my expertise to ensure that the quality control criteria at MicroCare is met and to assist in the development of new products.”

Mahoney earned a Bachelor of Science in Chemistry from Western New England University in Springfield, Massachusetts, and a Master of Science in Chemistry from Sacred Heart University in Fairfield, Connecticut.

SYBRIDGE, A TECHNOLOGY DRIVEN DESIGN AND MANUFACTURING COMPANY, SHOWCASED ITS NEW BRAND CAMPAIGN AND SHARED THE NEWS OF ANOTHER ACQUISITION AT MD&M WEST. MEDICAL PLASTICS NEWS SPOKE TO DEEPAK PRAKASH, VP OF MARKETING FOR SYBRIDGE, TO FIND OUT MORE.

While the company boasts about its medical device capabilities, it wants to expand this more, with an emphasis on life sciences going forward. With this goal in mind, the company announced the acquisition of Cavoform, a company that specializes in molding for medical devices.

Prakash said: “One of Sybridge’s secrets to success has been having all these acquisitions.

“They’ve come at a fairly brisk pace, but you know every one of those has brought on some capabilities that speaks to the unique and transformative journey Sybridge is on.”

After acquiring another company – Fast Radius in December –Sybridge was able to take the first step in creating a new brand campaign. The company was a digital manufacturing company and a “very exciting start up” that focused on multifaceted manufacturing capabilities, including 3D printing and CNC machining.

Prakash explained how one of the things Fast Radius did very well was to have a portal where you could upload and analyze your designs. So, whether a wall needed to be changed it could be analyzed and then 3D printed once the customer was satisfied.

“We love that capability because we can now put a lot of power in the hands of designers. This new campaign works by just sitting in front of the computer. The client can just upload the part into our portal and have it analyzed digitally.

“The client can approach the company and say ‘I have this design - can you test it? Can we manufacture it now?’ All of that can be done through a simple portal. Then if they’re interested and everything looks good, they can have a quick analysis of how much it would cost.”

The campaign was launched on 31st January, but had been in the works for several months beforehand. After successive acquisitions, the company is now able to bring the kind of scale it had set out to do.

Prakash claims the company is transforming the whole industry, bringing not only a digital transformation but also a ‘unique’ single platform to help customers along the journey and put the designer or manufacturer in control.

“You’ll see us being a prominent player in this digital transformation journey in this industry,” Prakash said. “Especially given some of our capabilities speaks very nicely to the life sciences marketplace, so you’ll see greater push from us putting our name out there.”

The future looks bright for SyBridge as the company position themselves as disruptors in the manufacturing space by bringing in technological capabilities that serve customers along their end-to-end development journey. A key aspect of that will be acquisitions, and SyBridge will continue to look for opportunities that allow for strategic expansion into high value market segments including medical and life sciences.