WE PACKAGE YOUR PRODUCTS!
INNOVATIVE, STERILE, LEGALLY VALID - INCLUDING THE NECESSARY STEPS FOR YOU TOWARDS MDR-COMPLIANT CERTIFICATION.
01 DEVELOPMENT
We offer you a packaging system individually adapted to your product and your needs. This can start with transport or cleaning trays and goes all the way through to the definition and design of a folding box.
We take into account product materials and geometries, the manufacturing process, the required cleanliness and the intended use of the product. Removal is included as well as the fulfilment of requirements in terms of mechanical strength and durability of the sterile barrier system.
All steps are carried out taking into account the requirements defined by standards.
Our engineers use the latest CAD software to design blisters and the necessary production tools, which are manufactured in our in-house toolmaking department.
02 PACKAGING KNOW-HOW
With experience from over 30 years in the field of sterile packaging, we can offer comprehensive and expert advice.
Necessary preparatory processes, such as cleaning in a cleaning process adapted to the product and the requirements, are part of a continuous process chain for us.
The selection of suitable packaging types, packaging materials or sterilisation methods takes place in cooperation with the customer.
Our specialist departments in the area of qualification and validation tasks ensure that the specified evidence and documentation requirements of all processes are taken into account.
The customer receives comprehensive advice regarding the possibilities in the area of sterile packaging as well as the expert implementation of the specified processes.
03 CLEAN ROOM PRODUCTION
The individual process steps from cleaning to packaging are carried out in ISO Class 7 and 8 clean rooms.
Clean room production ensures a clean environment and a consistent hygiene status for the products right through to packaging. The clean rooms are regularly subjected to qualification and meet the relevant standards.
The staff deployed in the clean rooms are specially trained for this work and are thus sensitised to the special requirements and correct behaviour.
04 VALIDATIONS
All machines used at steripac are qualified and subject to a strict maintenance interval.
The processes carried out on the machines are validated in relation to the product and revalidated at suitable regular intervals.
The validations carried out at steripac comply with the specifications and, together with the qualifications, ensure a consistently high quality of the products.
Through extensive documentation of the validation processes, we are able to provide our customers with the evidence necessary for the approval of their products.
The customer also has the option of having specially tailored validations carried out.
From cleaning and packaging to sterilisation or mechanical strength, we offer all the desired validation steps.
05 MDR CERTIFICATION
The European Medical Device Regulation (MDR / Medical Device Regulation 2017/745) poses new challenges for medical device manufacturers and their suppliers and subcontractors.
As a service provider for critical processes (sterile packaging), there are special challenges for us. The documentation of the processes carried out within our company must meet the new requirements and be structured accordingly.
Steripac has dealt extensively with the MDR requirements and adapted the documentation of the processes as well as general verification documents accordingly.
This makes it easier for our customers to obtain approval for an MDR-compliant product.
If you have any detailed questions about this, please contact us directly.
