Topics like work environment, costs as well as patient and user safety at the hospital pharmacies and the hospitals are in great focus. These are among the most significant elements that are part of the development of the primary packaging as well as transfer systems for infusion and injection therapy for both the present and for the future. This became clear at the resent Pharmapack fair in Paris where among others the Promens DivibaX® connection device was introduced.
Injection and Infusion Liquids
The current discussion is whether the hospital pharmacies should maintain/start their own production of injection and infusion liquids.
In countries like the Netherlands, Germany, Austria and Spain certain hospital pharmacies have their own production of special injection and infusion liquids that cannot be purchased from the industry or where the cost price is high. Some also choose to keep producing themselves in order to obtain certain independence as well as maintain the expertise and the know-how in regards to certain medicaments. In Denmark the 4 largest hospital pharmacies in Copenhagen, Odense and Aalborg produce large amounts of infusion and injection liquids – the packaging used is very often polypropylene containers and vials from Promens Medical Packaging A/S. Both the containers and the vials are developed in close co operation with these major hospital pharmacies to ensure that the products live up to the regulatory requirements and expectations.
It is possible with a relatively small investment to start filling infusion containers if you have the facilities for production with autoclave and water processing system. Some filling machines can even fill vials after a short and simple readjustment, as the neck dimensions are the same.
Infusion containers and vials from Promens are made of Ph.Eur. Polypropylene approved to products to be autoclaved after filling or Ph.Eur. Polyethylene for aseptically filled products. As the packaging is produced in a clean room with sterile filtered air the particle liability is far beyond the fixed threshold limit value. Every 24 hours samples are taken from the production for particle testing according to the Ph Eur paragraph 2.9.19. The testing is conducted at an external laboratory. The same testing is performed at the delivery of the raw material. Everything is documented thus the pharmacies can fill the products immediately without any price raising and delaying pre-wash, something that is necessary when using glass bottles.
Safe Transfer and Mixture of Medication
To ensure a rational and safe transfer and mixture of medication from the vials to the infusion container, Promens has developed together with the Danish hospital pharmacies the connection device DivibaX®. DivibaX® minimises the risks of contamination of intravenous medication and protects both the staff and the patients.
According to Hospital Pharmacist Leis Andersen from Odense University Hospital the advantages of DivibaX® are obvious:
- Easy to use
- Ready immediately
- Can be pre-assembled
- No physical contact with the active drug until the mixture is being made
- Can be pre-mixed
- Minimises the risk of spreading aerosole toxicological products
- Protects the user against needle stick injuries
- No separation possible after mixture ensuring 100% traceability
“In Denmark we focus on using closed systems when preparing infusion liquids instead of using syringes and needles as earlier.” says Leis Andersen.
Promens has the necessary competence to enter a close co-operation and solve specific issues for everyone’s satisfactory. Good examples are the Intra-Con IV container system, Medi-Con vials as well as the DivibaX®.
Promens Medical Packaging A/S has more than 40 years of experience in the development, production and sales of infusion containers, bottles for injectables and other types of bottles. Our products are sold to hospitals and to the medical and pharmaceutical industries world-wide.
Promens is mainly working in polypropylene and polyethylene with the benefit of a very comprehensive understanding of these plastics as well as the environmental friendly aspect. One of the main objectives is optimal patient and user safety.
DivibaX® is a registered trademark and the product is patented.
Promens Medical packaging is a part of the Promens Group with 60 factories world wide.
Originally printed in Hospital Pharmacy Europe magazine.