Packaging solutions for Life Science and Healthcare products

Our packaging solutions are designed for the highest demands in terms of cleanroom compatibility, process reliability and product traceability. They offer maximum product protection and therefore make a significant contribution to pack security.

MULTIVAC packaging solutions for sterile medical products ensure reliable, reproducible and traceable processes. Our machines are designed for low-bacteria and low-particle packaging of products in cleanroom environments.

Our packaging machines are designed to run rigid and flexible films, aluminium multi-layer films as well as paper-based materials and Tyvek®. This means a wide range of sterilisation methods are possible.

Typical areas of application for our solutions are:

• Catheters
• Single-use products
• Needles
• Suture material
• Implants
• Combi packs
• OP items

Thanks to our packaging systems with their GMP-compliant machine design, highly sensitive products can be packed flexibly and efficiently in single or combi packs. Our automation solutions in particular make a major contribution to achieving maximum process reliability and pack quality.

Our packaging solutions offer

• Optimum product protection (against environmental effects and product contact) as well as effective product location (in the pack)
• Tailored pack functions (opening aids, inner and outer packs, ...)
• Seamless traceability (serialisation, track & trace)
• Maximum security against product loss (prevention of cross contamination)

Typical areas of application for our solutions are

• Syringe
• Vials
• Ampoules
• Auto-injectors
• Active stents
• Combi packs
• Semi-manufactured products

Customers benefit from many years of experience in the sector, as well as from professional support by a specialised sales adviser locally and by a project manager at the company headquarters in Wolfertschwenden.

Every project begins with a clarification meeting, where the customer describes his particular requirements, states the challenges specific to the sector and product, and then defines his expectations - usually in the form of a User Requirement Specification. The MULTIVAC advisors will also at this stage put the customer's existing packaging procedures under the microscope.

Based on all the information collected, MULTIVAC then issues a proposal and quotation in close collaboration with the customer, as well as producing the necessary machine and format drawings. In many cases a number of possible solutions will be developed, and these will then be discussed in depth with the customer as part of a presentation.

Customers can test the feasibility of the proposed solution at MULTIVAC's Training & Innovation Center in Wolfertschwenden, where they can also take many other aspects into consideration. As part of this process, they can bring their own products and produce a wide variety of packs. If required, MULTIVAC will also produce packaging designs to the customer's particular specification.

As soon as the purchase order has been received, the internal production procedure starts and the project manager, as the central person within the procedure, clarifies the final interface configurations. He undertakes the communication with the customer and determines the machine design in so-called “Design review meetings”.

When final assembly and calibration have been completed, and the agreed Qualification Documents have been produced in Wolfertschwenden, the project is ready for the Factory Acceptance Test (FAT), where the machine is accepted by the customer.

As soon as the machine has been delivered to the customer, the team begins the process of installation and putting the machine into service, as well as conducting a Site Acceptance Test (SAT) if required and performing additional validation services. Instruction and training on the machine take place at the same time.

In the course of subsequent discussions, the customer can conclude an agreement with MULTIVAC for the servicing of the machine, or for regular recalibration and revalidation if necessary. MULTIVAC's worldwide after-sales service is always available locally in the event of problems, and it can supply genuine spare parts within a very short period of time.

Since the current MDR (Medical Device Regulation) has come into force, process validation has now become a statutory requirement. As a supplier of integrated packaging solutions, MULTIVAC has many years of well-founded expertise. Our team of experts can offer you comprehensive support in implementing your requirements from start to finish.

Our package of qualification and validation services meets the GMP, GAMP 5 and ISO regulations, and this includes the following services:

• Validation schedule
• Risk analysis
• Function specification
• Installation and operation qualifications
• Computer validation

We also support you in conducting qualification and validation procedures on site, as well as assisting you in creating special or retrospective validation for packaging solutions that have already been installed.

In order to comply with the requirements of FDA CFR 21 part 11, our IPC machine control can be equipped with the following functions for the monitoring and recording of the packaging process:

• Personalised user administration
• Password management
• Audit trail
• Recipe history
• Data backup
  
  

In order to ensure the packaging process and pack quality are always reproduced, we conduct calibration procedures for the process parameters that are relevant to the particular packaging line. We record the results in a calibration protocol and make the corresponding documentation available to you for the correction of measurement deviations.

From the initial idea to the first test run - a competent and experienced project team will be at your side during the implementation of your packaging solution, a team that will accompany you from the first evaluation to the final completion of the packaging project.
Our complete range of services is rounded off with the full training of your staff and the final customer acceptance of the installed packaging solution.

We offer comprehensive training courses for you to become familiar with the operation, servicing and care of your machine. Either at our worldwide training centres or with you on site. The coaching is practically based and is carried out right at the machine, and you also receive the written training material at the end. In this way, you can fully realize the potential of your new MULTIVAC packaging solution.