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STERILE HYDROGEL DRESSINGS


   
   
     


TECHNOLOGY ESSENCE

 

 

Part of this technology was developed inside an International Atomic Energy Agency program and it was based on previous development from a Polish University. As it was a cooperation program there is no previous intellectual property rights to be addressed.

The technology is characterized by four stages:

1. Preparation of an initial solution, being this solution a mixture of polyethylene glycol, polyvinylpyrrolidone and agar. This solution is easily prepared at 60ºC in a common reactor with a conventional propeller mixer at low speed. It is a clear homogeneous viscous liquid (this technology was transferred by IAEA cooperation).

2. The solution is added to appropriated molds and it is allowed to be gelled at room temperature. The molds can have any size and shape. The gelling time is usually just a couple of minutes without any external refrigeration system;

3. The mold filled with the gel is packed (sealed) by any suitable technology for medical products. Cheap and conventional techniques can be easily applied.

4. This packed gel is sterilized under ionizing radiation at 25 kGy total dose. The same sterilizing dose is used to promote simultaneously the crosslinking of the PVP molecules creating a flexible and resistant material composed almost only by water. In conclusion it is a way to produce solid and flexible water. Immediately after sterilization/crosslinking the hydrogel membrane will acquire the useful mechanical properties and as a sterile material can be commercialized and used as a dressing.

Biolab developed its own production process based in these four steps. Patents are being applied covering all aspects of this technology. So far, Biolab process is able to produce 30 dressings (15cmmX 12 cm) per minute with just one packing machine. About US$100,000.00 is necessary to establish a production line.

 
 

DRESSING PROPERTIES

 

 

This dressing is produced with pure water and biocompatible medical grade polymers, being sterile as a result of the irradiation process. It passed already “in vitro” biocompatibility essays. Clinical test are under way in Brazil, but similar products are being used and approved by European community countries.

The main properties are as follow:

• It prevents the formation of overgrowing scars and ensures stable humidity of the healing environment promoting faster healing;

• It reduces dramatically the pain, due to its softness and flexibility;

• After the dressing application, it promotes the temperature reduction of the wound increasing the comfort even further and controlling the inflammatory response;

• It forms a barrier for bacteria from outside, which promotes the sterility of the wound;

• It protects against loss of the body fluids;

• It provides oxygen access to the wound;

• It is moldable to many body shapes as a result of its softness and flexibility;

• It shows good adhesion to the skin, without any adhesion to the wound;

• By just dipping the membrane in an aqueous solution drugs can be incorporated. So it allows the simplest way to promote the slow drugs delivery according to each medical staff recommendation;

• No allergic response was detected so far;

• During the dressing changes, the secretions are removed from the wound leaving undamaged granular tissue.

The dressing can be used in the treatment of burn wounds as well as in the treatment of “difficult to heal wounds”, for instance bedsore, ulcers etc.

 

FMS - Flexible Manufacturing System

The Bandgel ® manufacture is developed generating a modeling approach for the design of Flexible Manufacturing Systems (FMS) using a concurrent engineering approach to use a particular FMS - Blister Packing integrating irradiation process (sterilization).

A FMS is defined as an integrated and automated production system containing:
(a) flexible process equipment, normally automated machines with numeric control and equipped with quick tool change ability,
(b) material handling equipment including transfer lines or conveyor belts, forklifts, elevators, automated guided vehicles (AGVS) as well as automated storage and inventory handling systems such as automated storage and retrieval systems (ASRS),
(c) sophisticated computerized communication and control systems integrating process and material handling equipment, and
(d) a modern maintenance support structure that can bring the system quickly back to normal after equipment failure.

 

R & D
RESEARCH & DEVELOPMENT

Dr Ademar Lugão

IPEN | BIOLAB

 

INTERNATIONAL LICENSING

Dr Mathieu North
Switzerland


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