Interim report: The expansion of the French location of SÜDPACK MEDICA is on schedule

On September 19, 2023, the starting signal was given. Now, just one year after the groundbreaking, construction work is in full swing. The expansion of the French site of SÜDPACK MEDICA in Coulmer in the Orne region is on schedule – and it is the largest individual project of the SÜDPACK Group of Companies. With commissioning scheduled for July 1, 2025, the area for cleanroom bag production will have doubled compared to current capacities.

The site represents SÜDPACK MEDICA's approximately 35 years of expertise in cleanroom bag manufacturing. The specialized plant in Normandy is focused on the production of sterilization barrier systems for medical technology and diagnostic applications, as well as primary packaging for pharmaceuticals and product-contacting components of Active Pharmaceutical Ingredients (API) – and is certified according to ISO 13485 and 15378.

"With the expansion of the cleanroom area with ISO7 certification and the particular focus on low particle load, we can now position ourselves even more strongly in the pharmaceutical sector, in addition to the medical device industry," explains Managing Director Thomas Freis. A strategically important decision for SÜDPACK MEDICA because the demand for sterilizable cleanroom bags is continuously increasing, and the market therefore offers significant potential. Especially for those involved in the process chain dealing with the production of liquid dosage forms of medicines, low particle contamination is a relevant issue: glass bottles, ampoules, or syringes used for administering liquid parenterals such as infusions must carry a low particle load before filling to prevent the entry of foreign bodies into the patient's bloodstream or at least keep it as low as possible.

The Product and Service Portfolio of SÜDPACK MEDICA

…is consistently aligned with market demands and customer needs. Thanks to a vertically highly integrated, circular value chain, the range extends from compounding and extrusion to lamination, printing, and bagging, as well as the recycling of post-industrial materials. In the standard bag segment, the variety is particularly impressive: the most common applications in the medical and pharmaceutical sectors can be optimally covered. The Coulmer specialists are also capable of implementing specialized process solutions in complex pharmaceutical productions.

Three-Side Seal Bags

Investments have already been made in recent years in pouch and three-side seal bag systems to meet the increased demand for films and bags that can also be used at various points along the value chain in the pharmaceutical industry. Today, SÜDPACK MEDICA's range already offers a wide selection of sealed barrier bags for nearly every requirement – with an increasing trend.

The small-format bag solutions are typically used for packaging components such as stoppers or filters for liquid dosage forms. Larger formats are available for prostheses, instruments, wound care products, and surgical textiles. The combination of stable carrier films and gas-permeable lid films enables gamma sterilizable high-barrier packaging as well as packaging concepts suitable for gas-based sterilization, such as ethylene oxide (ETO sterilization). Additionally, fully film-based three-side seal bags with peel systems are also possible.

The variety of formats, material combinations, printing colors, and opening systems is enormous: "Our customers find perfectly suitable high-barrier bags for their specific needs – either made from film or also as a combination with Tyvek® or medical paper. The production of bags, narrow rolls, and lids always takes place under ISO7 and ISO8 cleanroom conditions," emphasizes Thomas Freis.

Pouch Bags

The conventional and sustainable pouch bags of SÜDPACK MEDICA meet all specific requirements for stability, transparency, barrier properties, and efficiency – without side seams and migration risks. They are also produced under cleanroom conditions.

While the pouch bags made from blown films based on pharmacopoeia-compliant raw materials also exhibit excellent opening behavior, coextrusion solutions offer very good performance in terms of puncture resistance. They are also used as secondary packaging for bio-processing bags.

A significant advantage for customers: the standard bag concept allows for even small order quantities. Delivery times are also short because common sterilization barrier materials from various Tyvek® grades (coated and uncoated) and medical papers from leading manufacturers are kept in stock. Moreover, thanks to modern production equipment, standard products can be quickly adapted to the individual needs of customers. And: by roll cutting sterilization barrier materials in the cleanroom, flexibility increases – on the part of customers as well as SÜDPACK MEDICA.

Tyvek® Patches in Bag Packaging

With strategically applied Tyvek® patches on the back of the bag, SÜDPACK MEDICA enables a quick and effective gas diffusion process during ETO sterilization. Thomas Freis explains: "This combines the advantages of pouch packaging with the possibilities of gaseous sterilization. Customers do not have to give up the familiar good opening behavior, which can be supported by a tear notch if needed. Tyvek® is particularly characterized by its outstanding peel properties and high puncture resistance. It is tear-resistant and moisture-resistant – and naturally forms an extraordinarily high microbial barrier." Typical applications include bag packaging for wound care products, operating room sets, or dialysis filters.

With the expansion of the Coulmer site, SÜDPACK MEDICA is well prepared for future requirements. Thomas Freis is pleased: "If we can actually stick to the schedule – and it currently looks like it – we will already place the first machines in the middle of next year. From the end of July, we will then gradually start production in the new facilities."