Through close collaboration with our customers,
we provide solutions that meet specific needs, from standard stock items to customized technical films.
Our products, made from polymeric materials, are optimized for the healthcare sector with a focus on both functionality and sustainability. We ensure that all products comply with regulatory requirements and meet both customer and legal standards.
We are proud to be ISO 9001 certified,
underscoring our commitment to global standards of quality management
This certification ensures that our quality management system aligns with international best practices, allowing us to consistently meet customer and regulatory requirements. Additionally, our use of a modern Quality Management System (QMS) enables us to continuously monitor, control, and improve our processes through advanced technology and comprehensive quality protocols.Standards guarantee that both the manufacture and the products fulfil the requirements that are placed on the company by the customers and society in general. Compliance with these requirements is controlled by means of regular audits by independent auditors from Notified Body and importantly, our customers.
Rigorous in-line and off-line quality control
Packaging Films and Performance Films are checked in-line during the production process using various technologies for deviations. Other important parameters, such as thickness and width and other dimensions, are also checked continuously during production. Furthermore, we arrange additional testing programs, e.g. bio-burden testing and sample preparation for dose audit/dose mapping.
Daily monitoring and control
of our processes guarantee continuous improvements
Our employees play a key role in delivering the right quality at every stage, from production to final delivery. The principle of "Right from Me" means that each employee takes responsibility for ensuring the correct quality is passed on to the next stage in the process, whether it be in direct production or in supporting processes.
We ensure that every product meets the promised delivery quality, ensuring satisfied customers who return. This also includes how we handle situations where promises need to be fulfilled. The company management ensures that sufficient resources are always available to maintain these quality standards.
Cleanliness and Hygiene in Processes and Production
At Alfapac, cleanliness and hygiene are top priorities, especially when producing materials and packaging for sensitive industries such as pharmaceuticals, medical technology, and the food industry. We adhere to strictly controlled hygiene routines to ensure our products meet the highest cleanliness standards, which are critical in these sectors where safety and purity are paramount.
When producing packaging for pharmaceuticals and medical devices as well as films for medical devices, we follow Good Manufacturing Practice (GMP). Alfapac uses only approved and certified materials for packaging that comes into contact with food and sensitive medical products, providing our customers with confidence and assurance in the safety of our products.
Quality routines
Controlled production environments
Our manufacturing facilities maintain high levels of hygiene through meticulous cleaning and disinfection routines, reducing the risk of contamination.
Full batch documentation
Traceability of products and raw materials is part of our standard procedures. Batch documentation is retained for at least five years.
Strict hygiene rules for personnel
Our staff follow established hygiene protocols, including the use of protective clothing, gloves, and sterile equipment, ensuring products are handled safely and hygienically.
Ongoing cleanliness checks
Regular inspections and testing are conducted to ensure our production processes meet both internal and external cleanliness and safety requirements.
Regulatory compliance
Unique products can also comply with the requirements of for example ISO 13485 and CE.