Gerresheimer Peachtree City (USA), L.P.

650 Highway 74 South
Peachtree City,  GA  30269

United States
https://www.gerresheimer.com

• Booth: 4837

Gerresheimer Medical Systems is an international acting product development, industrialization and contract manufacturing partner for customized laboratory disposables, point-of-care tests and medical products. Our service range includes product and process development, engineering, moldmaking, automation engineering, small and large scale production according to FDA/GMP (cleanroom), product refinement, assembly and packaging. We offer production sites in Europe, USA and Asia.

 Press Releases

• Gerresheimer establishes small series production in the USA (May 30, 2022)

  Pilot production in series quality at the Peachtree City production plant: Development samples, clinical samples all the way to small series production in every project phase for the company’s American customers

  Peachtree City, June 2022: Pharma and medical technology specialist Gerresheimer has established small series production at its Technical Competence Center at its Peachtree City, Georgia location. Small quantities of products can now be manufactured under series conditions and in ISO class 8 cleanroom. During the development and approval of pharmaceutical products and medical devices, this kind of small series is regularly needed for clinical samples or stability batches.

  Prior to series production, pharmaceutical products and medical devices run through an exhaustive approval process for which small numbers of units need to be produced repeatedly, for examples, as clinical samples, development samples or stability batches. In 2013, Gerresheimer opened its own small series production at its Technical Competence Center in Wackersdorf, Germany, to accomplish this task. The company is now continuing this success story, starting small series production at its Peachtree City production location to be able to offer American customers small series production locally.

  Besides providing small volumes of product, small series production also enables Gerresheimer to optimize the production process in the pilot phase. All the expertise required for series production can be established, while processes can be developed and streamlined. The experience gained during mold making and automation can be harnessed to design series molds and series equipment.

  Setup of small series production began at the Technical Competence Center at the Peachtree City location in 2020 with the conversion of an existing building as well as setup of an ISO class 8 cleanroom in accordance with DIN EN ISO 14644-1. Small series production then took up operation in 2021. “The equipment in small series production adapts to the project. We are currently producing an innovative product for ophthalmology, an innovative point-of-care test system and a combination product in accordance with the FDA definition,” explains Manfred Baumann (Global Executive VP Sales & Marketing, Administration & TCC, Gerresheimer Regensburg GmbH).  Based on these projects, the equipment in small series production currently includes an injection molding machine with a clamping force of 120 tons that connects with handling systems and parts conveyors. Project-specific assembly and packaging units such as granulation, fill & seal plants as well as manual assembly stations, including ultrasonic welding systems, are also available. For quality assurance, small series production has its own fully equipped measurement laboratory with product-specific testing equipment with optical and tactile measuring machines and other testing equipment.

• Gerresheimer develops test cartridge and reagent block for an innovative blood analyzer (May 30, 2022)

  Initially, Gerresheimer provided the customer with several concepts for both the test cartridge containing the analyzer’s innovative biochip and the reagent block, from which up to four test fluids (reagents and sample diluents) are supplied and waste products are purged after testing.

  For the final design of both components, elements of various drafts were combined and optimized. In developing the test cartridge, the initial focus was on improving the ergonomics of the glass capillary holder, which is where the patient’s blood sample is stored. A corrugated finger rest and two extended guide rails make sure that the delicate capillaries can be inserted safely into the cartridge.

  Two O-rings also ensure the glass capillary tube is sealed in the cartridge. The cartridge itself was rounded to simplify production using injection molding. Ultra-transparent COP plastic was selected as the material for parts of the cartridge so that the user can check to make sure the capillaries are filled completely before inserting them into the test unit.

  In designing the reagent block, Gerresheimer reduced and standardized the thickness of the block walls to achieve the highest possible stability and production speed with the lowest possible material costs.

  CAMPTON Diagnostics selected Gerresheimer as their development partner because the company offers agile project handling and can quickly and flexibly implement changes.

  “We are well positioned to work both with start-ups and large pharmaceutical companies,” explains Manfred Baumann (Global Executive Vice President Sales & Marketing Administration & TCC). “Thanks to our multi-stage Gx phase model, we can optimally adapt to the needs of our customers. For start-ups especially, fast availability of functional prototypes or small series is critical for clinical testing.”

  For the blood test, small amounts of capillary blood are taken from the patients, for example from a drop of blood. The blood is drawn by a glass capillary, which is inserted into the test cartridge. Next, the cartridge and reagent block are inserted in the unit. On the cartridge biochip, disease-specific biomarkers in the blood react with the corresponding antibodies on the chip. With the unit, indications of various infections and types of cancer or autoimmune diseases can be identified right at the point of care, depending on the test cartridge used, and samples no longer have to be sent to the lab and await analysis.

• A new DPI device for the generic drugs market (May 30, 2022)

  Wackersdorf, June 2022: Gerresheimer has assumed responsibility for the industrialization of a dry powder inhaler for the treatment of respiratory ailments for MERXIN (United Kingdom), a company that specializes in making inhaler devices. The inhaler is produced in Pfreimd (Germany) for worldwide distribution. Beyond the technically sophisticated industrialization of the product, the main challenge of the project was to coordinate an optimal development process aimed at ensuring the shortest possible time to market at the lowest cost.

  MERXIN MRX003 capsule dry powder inhaler is used for pulmonary delivery and in particular for the treatment of chronic, obstructive pulmonary diseases (COPD) and asthma. The API is aerosolized and distributed with the respiratory system to find its way deep into the lungs of the patient. The correct interplay of inhaler and formulation plays a decisive role in the success of the treatment.

  The first product target for MRX003 was a generic version of an API. Because of the nature of the generic market, it was of essential to achieve the shortest possible time to launch. This was achieved through a close cooperation between the partners. Decades of expertise and know-how in inhaler design and production were combined between Gerresheimer and MERXIN. Jochen Wegerer (Program Manager, Gerresheimer Regensburg GmbH, Wackersdorf) was impressed by the cooperation: “The good teamwork within the project is noteworthy. Challenges were always discussed in a goal-oriented, creative, and open manner, so that approaches to solutions could be formulated and implemented within the shortest time possible.”

  The design of the manufacturing process of MRX003, had to deliver high product quality with the most stable, fully automated processes possible and to enable affordable production for the generic drugs market. “With the help of our DMF package, we were able to create, implement, and qualify the molds to be very robust,” Richard Gradl (Mold Engineer, Gerresheimer Regensburg GmbH, Wackersdorf) explains. “The stable component quality and high process capability of the molds ensure good conditions in the series production environment.” Our risk management approach was based on procedures that were tailored to the special features of the project, from qualification and validation to long-term production security, as highlighted by Tobias Bernklau (Global Head of Quality Engineering, Gerresheimer Regensburg GmbH, Wackersdorf): “The focus is always on the user for all decisions. For critical areas and functions, we deliberately invest more effort than for less critical areas and functions.”

  MRX003 is assembled from a total of 12 parts, meaning seven injection molding parts of ABS or MABS (base element, capsule housing, hinge plate, button, mouthpiece, filter housing, sealing cap) as well as five stainless steel bought-in components (two lancets, spring, cylinder pin, and fine filter unit). A pouch is used for the packaging of the finished product. For the BICs, Gerresheimer selected suppliers who are capable of fulfilling sophisticated quality. The injection molding parts are produced at the Gerresheimer location in Pfreimd in multi-cavity tools. The fully automated assembly and gap-free testing of each individual inhaler takes place at three round table stations.