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Contract Manufacture - Sterile Parenterlas

Demand for contract manufacture of evacuated sterile parenteral product

Client of Farmavita.Net is looking for contract manufacturer for the production evacuated, sterile glass bottles used for autohemotherapy with medical ozone.

The manufacturing process would include following main steps:

Solubilization of sodiumcitrat (anticoagulant) in water for injections.
Filling of 12 ml of sodiumcitrat solution into 250 ml glass bottle
Assembly of the glass bottle with the closure cap including a tube (closure will be provided by our client)
Closure of bottle and evacuation of the bottle to -0,75 to -0,88 bar. The vacuum is used for the blood taking process.
Heat sterilization

Process is well established by client and there are not technical concerns.

The quantity is estimated for about 200.000/year.

Product is dedicated to EU market. GMP certificate from EU Authority is not necessary, but will be an advantage; ISO 13485 certification would be of further advantage, since the product is a medical device.

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