Work began at the new facility on September 19, 2023. Now, just one year after the groundbreaking ceremony, construction is in full swing. The expansion of Südpack Medica’s French site in Coulmer, located in the Orne region, is on track - and it is the largest single project within the Südpack company group. When operations at the site begin on July 1, 2025, the area dedicated to cleanroom pouch production will have doubled in compared to its previous capacity.
The site reflects Südpack Medica’s 35 years of expertise in cleanroom pouch manufacturing. The specialized facility in Normandy focuses on pro-ducing sterile barrier systems for medical technology and diagnostic applications, as well as primary packaging for pharmaceuticals and product-contacting components of Active Pharmaceutical Ingredients (API). Accordingly, the Coulmer site is certified in accordance with ISO 13485 and 15378.
“The expansion of our ISO7-certified cleanroom facility, along with our strong focus on minimizing particulate load, will allow us consolidate our position in both the medical goods and pharmaceutical industries,” explains Managing Director Thomas Freis. "This is a strategically important decision for Südpack Medica, as demand for sterilizable cleanroom pouches continues to rise, presenting significant market potential. Reducing particulate load is a critical concern, especially for manufacturers involved in the process chain for liquid pharmaceutical dosage forms. Glass bottles, ampoules, and syringes used to administer liquid parenterals, such as infusions, must have minimal particulate contamination before filling to prevent the introduction of foreign particles into the patient’s bloodstream.”
Südpack Medica’s product and service portfolio
… is consistently aligned with market demands and customer needs. With a vertically integrated, circular value chain, the company’s product spectrum ranges from compounding and extrusion to laminating, printing, and pouch production, and even includes the reprocessing of post-industrial materials. In the standard-pouch segment, Südpack Medica’s impressively broad product range ensures optimal coverage for most common applications in the medical and pharmaceutical sectors. Beyond this, the specialists in Coulmer can also deliver tailored process solutions for complex pharmaceu-tical products.
Three-side-seal pouches
In recent years, the company has invested in flow pack and three-side-seal pouch machines to meet the growing demand for films and pouch-making materials that can be utilized at various stages of the value chain, including in the pharmaceutical industry. Südpack Medica now offers a wide range of sealed barrier pouches for nearly every requirement - in response to steadily increasing demand.
Small-format pouch solutions are commonly used for packaging compo-nents such as stoppers or filters for liquid dosage forms. Larger formats are available for prosthetics, instruments, wound care products, and even surgical textiles. The combination of durable carrier films and gas-permeable lidding films enables high-barrier packaging that is gamma sterilizable, as well as packaging concepts suitable for gas-based sterilization, such as ethylene oxide (ETO) sterilization. Additionally, fully film-based three-side-seal pouches with peel systems are available.
The available formats, material combinations, inks, and opening systems are extensive. “We offer our customers high-barrier pouches perfectly tailored to their specific needs - whether made entirely of film or combined with Tyvek or medical paper. The production of pouch-making material, narrow rolls, and lids always takes place under ISO7 and ISO8 cleanroom conditions,” emphas Thomas Freis.
Tubular bags
Südpack Medica’s conventional and sustainable tubular bags meet all the specific requirements for stability, transparency, barrier performance, and efficiency - without side seams or migration risks. These bags are also produced under cleanroom conditions.
While tubular bags made from blown films using pharmacopoeia-compliant raw materials are characterized by excellent opening properties, coextrusion solutions offer excellent puncture resistance and are also used as secondary packaging for bio-processing bags.
A key advantage for customers is that Südpack Medica’s standard pouch concept even allows small order quantities. Additionally, delivery times are short, as common sterile barrier materials made from various Tyvek grades (both coated and uncoated), as well as medical papers from leading manufacturers, are readily available from stock. A further benefit is that, thanks to modern production equipment, standard products can be swiftly tailored to meet the needs of individual customers. Moreover, by slitting sterile barrier materials in the cleanroom, flexibility is increased - both for customers and for Südpack Medica.
Tyver patches in pouch packaging
By incorporating strategically placed Tyvek patches on the back of the pouch, Südpack Medica facilitates a fast and efficient gas diffusion process during ETO sterilization. Thomas Freis explains: “This allows us to combine the benefits of tubular pouches with the advantages of gas sterilization. Customers don’t have to sacrifice the excellent opening behavior they are accustomed to, which can be further enhanced with a tear notch if required. Tyvek is well known for its excellent peelability and high puncture re-sistance. It is tear-resistant and moisture-resistant - and naturally provides an exceptionally effective microbial barrier.” Typical applications include pouch packaging for wound care products, surgical kits, and dialysis filters.
The expansion of the Coulmer site will ensure that Südpack Medica is well-equipped to meet future requirements. Thomas Freis: “If we can stay on schedule - and it looks like we will - we plan to install the first machines by the middle of next year. By the end of July, we will gradually begin production in the new facility.”
