Sterile Powder for Injection

November 6, 2020 by pharmavision0
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Vision Pharmaceutical’s powders for injections are sterile, pyrogen-free powder substances including our lyophilized material packed in glass container. When sterile water for injection (provided in the packaging) is added into this powder it rapidly form a clear solution that can be injected intravenously or intramuscularly.

Parenteral preparations may require the use of excipients such as solvents, substances to enhance solubility, suspending agents, buffering agents, substances to make the preparation isotonic with blood, stabilizers or antimicrobial preservatives. Vision Pharmaceutical ensures that these addition of excipients is kept to a minimum. Our R&D department thoroughly investigate and then recommends specific excipients so that they do not adversely affect the stability, bioavailability, safety or efficacy of the active ingredient. It is ensured that all the components of the dry powder ampules are perfectly compatible with each other.

Manufacture:

Vision Pharmaceutical strives to make sure that our manufacturing process meet the standard of cGMP. The following main general guidelines are followed at every step of production to meet the requirements.

The quality and grade of raw material, manufacturing machinery, maintenance of the equipment and the method of powder production is maintained at highest standard to ensure the stability of the active substance and of the final product and that the final product is sterile and free of pyrogens and particulate matter.

If any antimicrobial agent is added, the quantity is kept minimum and according to guidelines provided by regulatory authority. Sterilisation is performed prior to production and is maintained throughout the procedure. For glass container sterilisation autoclave is the preferred method because it ensures rapid and complete sterilisation.

Vision Pharmaceutical is extra cautious in filling of oxidation sensitive formulas and filling of such powder is done in the atmosphere of suitable sterile inert gas, such as nitrogen, whereby the air in the container is replaced by this gas.

Suitable and controlled particle size in maintained, dependent upon the intended use of the dry powder formulation.

Vision Pharmaceutical monitors manufacturing process by validation and carrying out appropriate in-process controls. These are chalked out in a way to guarantee effectiveness of each stage of production. Monitoring of environmental conditions (especially with respect to particulate and microbial contamination), bacterial endotoxins, pH and clarity of solution, freedom from particulate matter and integrity of the container-closure system (absence of leakage, etc.) are of utmost importance in this regard. We ensure that production procedure of powders for injections must include uniformity of mass, moisture content and the ease of reconstitution.

Our quality control department validate every production phase and inspect final product for particulate matter, discoloration, precipitation of solid matter and other sign of chemical or physical instability. Vision Pharmaceutical guarantees that all our parenteral preparations comply with Test for sterility, Test for bacterial endotoxins, or, where applicable with Test for pyrogens. In single active ingredient formula it is ensured that the powder must be of uniform mass and particle size.


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