validatable Audionvac – Vacuum sealing specialized medical products
Our customer in this case study is a leading manufacturer of medical implants and surgical instruments
Customer profile:
With more than 40 years of expertise, our customer in medical industry has been manufacturing implants as well as state-of-the-art medical instruments for traumatology and orthopedics. They are established in Bialystok in the north-eastern region of Poland (the European area known for its ecologically clean environment). Their customized medical products are renowned for the comfort and safety they provide for both patients and surgeons. Specialized healthcare providers therefore successfully apply their solutions to their patients, helping thousands of people to improve their health.
A modern machine park enables the production of innovative designs according to the latest technology, which quality and safety is precisely controlled in their accredited laboratories. This enables them to be a reliable source for the ongoing innovative traumatological and orthopedic solutions.
Challenge:
To respond to the rapidly increasing safety requirements in medical markets and the growing market demand, we wish to implement a vacuum sealer that improves the seal integrity and safety of our products, while increasing our packaging output.
Packaging was done on a vacuum sealer processing one product at a time, limiting our customer’s production capacity and leaving opportunity for improvement.
The company had recently switched from Tyvek for its packaging to PE film to improve their packaging flexibility and production speed. The ideal machine needed to be able to achieve a maximum vacuum level, provided with a validated and strong seal in order to safely pack artificial bones of different types and sizes. This requirement was mostly needed to keep the product in a secured position within the bag to avoid damaging of both the film and item. A positive side effect would be the direct reduction in the required storage and transportation space.
Following the high standards in medical industry regarding packing instruments and implants, the machine needed a validation feature with official certification. Their cleanroom complies with cleanroom ISO 7 classification and uses a centralized clean air station, where air flow is supplied by a 7 bar air compressor. In addition, HEPA filters are used to protect from harmful airborne particles and illnesses.
Audion packaging solution:
Using the provided URS document, Audion recommended the validatable VMS 333 as the best solution for the job.
Specifications of the recommended VAL VMS 333:
- Semi-automatic vacuum packaging
- Validatable 10 mm impulse seal
- Convenient collapsible table – Special engineered to accommodate the printer
- Easy-to-use Audion Touch Techware – combi of advanced Audion software and touchscreen
- 50 program memory – Unique (product type/size) seal parameter recipes always at hand
- Soft air feature – To safely pack sharp products without damaging the film
- User-level rights secured with a password
- Capable of reaching a vacuum level of 99.9% (= 25 hectopascals) – Fixates the product inside the bag
- Barcode scanner and Labeler
- Perfect to seal OPA-PE bags ranging from 75x180mm to 110x520mm
- Suitable for use inside a cleanroom environment
The machine’s bi-active seal bars produce a high quality 10 mm seal (standard is a secure 8 mm seal) ensuring ultimate safety of the package in combination with a vacuum level up to 99,9 percent (= 25 hectopascal). This keeps the product in a steady position inside the bag, minimizing the package size while reducing storage and transport space/costs.
The Audion VAL VMS 333 complies to ISO 11607-2 validation requirements for sealing. The controlled and monitored critical process parameters are:
- Vacuum / gas pressure
- Seal temperature
- Seal time
- Seal pressure
The VAL VMS 333 is equipped with the easy-to-use Audion Touch Techware that runs on advanced Audion software and is operated by means of a touchscreen control panel. For ultimate control over the packaging process, this machine included the optional ‘user level rights’ feature. This enables individual password-protected user-permissions to be granted based on 3 levels (supervisor, administrator or operator). A convenient labeler prints the batch data containing the time, employee number or name and confirms the successful completion of the package. This assures the product can be sent safely to the next step in the supply-chain.
End result:
With the implementation of the validatable Audionvac VMS 333 in our customer’s production process, they benefit from the highest level of packaging safety, a high level of optimized operational comfort and significantly improved packaging efficiency, due to the semi-automatic aspect and the ability to process multiple items simultaneously. The integrated Audion Touch Techware facilitates optimized seal integrity and a validation process that fully meets the stringent requirements in medical business.
We are confident this customer is ready for their promising future ahead, especially since the successful implementation of their first Validatable Audionvac has resulted in another machine order, contributing to even more production efficiency.
Widget 3
Hogeweyselaan 235
1382 JL Weesp, The Netherlands
T: +31(0)294-491717
E: info@audion.com
BTW: NL803873104B01
KvK: 32057820
Audion Elektro Ltd.
Unit 4, Centurion Way Business Park,
Alfreton Road, Derby
DE21 4AY, United Kingdom
T: (0)1332 404330
VAT 302127615
Company No 03856331
Audion Elektro B.V.
Hogeweyselaan 235
1382 JL Weesp, The Netherlands
T: +31(0)294-491717
E: info@audion.com
VAT: NL803873104B01
Trade reg. Hilversum: 32057820
Audion Elektro GmbH
Karl-Kisters-Straße 8
D-47533 Kleve, Germany
T:+49(0)2821-7330-0
office@audion.com