Technology for your health
Cement for Vertebral
Augmentation
Technology for your health
Company presentation
The company VHERN srl is an original supplier of bone cement. The managers, in the biomedical field for over 20 years, joined in 2011 and they founded this company in order to produce in particular a specific medical device: bone cement for vertebral consolidation and kyphoplasty.
In 2012, the company obtained ISO 13485 certification and certification of medical device compliant with CE regulations.
In 2015, the company brought its headquarters to the Fratta plant Polesine (RO), in Via Saragat 190, as an equipped and compatible structure for the production of the medical device in question.
The Vhern company:
It does not use any OBL license or contract from any other manufacturer.
Develop the products in their own laboratories independently.
What we do
VHERN production consists of:
- VERTEBROMIX, bone cement for severe or multiple surgical proceduresfor Vertebroplasty or Kyphoplasty applications
- VERTEBROMIX FAST, bone cement for short-term operations forapplications of Vertebroplasty or Kyphoplasty
- ORTIMIX, bone cement with standard viscosity for surgical use arthroplasty procedures with manual applications (1)
- ORTIMIX LV, bone cement with low viscosity bone cement for use surgical procedure in syringe applications (1)
(1) in production since July 2014
The product
Bone cement is composed of 2 main components: powder and liquid.
The production of the kit consisting of the two components requires an environment sterile, therefore the production process is carried out in 2 Clean Rooms of different classes, ISO 7 and ISO 5 respecting the ISO 14644 standard, and different ones equipment and instrumentation.
Storage in the warehouse is guaranteed in a temperature system controlled between + 5 ° C and + 25 ° C, controlled by digital Dataloggers.
Transport is guaranteed by refrigerated transport, by companies specialized in the controlled temperature transport of drugs and devices medical and ISO 9001 certified.
The entire production procedure is performed by carefully following the procedures required by ISO 5833 specifications for acrylic resins of inter and intraosseous cements and implants.
VHERN Bone Cement has obtained the CE Mark and the ISO Mark as manufactured in compliance with European regulations 93/42 / CEE, in compliance with the ISO 9001: 2015 and ISO 13485: 2016 EC standards.
All the processes involved in the production of bone cement are been validated, and many of which were performed by Laboratories ed Independent organizations, all accredited according to the UNI EN ISO standard 17025 and certified by the Ministry of Health.
Some of the most important processes are:
- Microfiltration test
- Steam sterilization test of production systems
- Physical and mechanical tests of tensile / compressive strength
- Packaging Test
- Shelf-life test
- Breakdown into vials
- Gamma ray sterilization test
- Ethylene Oxide Sterilization Test
Clinical evaluation and biocompatibility
The clinical evaluation was carried out on the product, according to the guidelines expressed in 06/2016 of MEDEEV 2.7.1 rev. 04 and the evaluation of biocompatibility according to the legislation in force.
From the evaluations carried out the product has been defined completely safe and biocompatible for the uses mentioned above.
Production
The production system has led to the definition of 5 product factors you can frame in 5 main groups of operations:
A. Clean Room ISO 7, the clean room, the work environment
B. The Notified Certification Body. Bone cement like any Implantable medical device in the human body needs a tight fit control by a Notified Body that is responsible fordecide if the requirements of the current regulations are met
C. Validation and testing processes, those specific for bone cement
D. Equipment and tools for laboratory analysis and control of production, according to the European safety and quality standard. The equipment most significant are: automatic machines for filling the vials of monomer and their automatic closure (capacity of 1500 vials / hour), the clean room ISO 5, the liquid microfiltration system with control of particle safety not exceeding 0.2 micron, equipment for the mixing powder / dosage, the thermal sealing system of the pack in double rigid blister, etc.
D. The know-how. Knowledge of technological processes, formulas from raw material used and the procedures to reach the finished product.
E. Last, not to mention the most important, RESEARCH. His contacts scientific, the future.