This will also elevate the number of quality concerns that will result into below from government authorities:
- Product Recall
- Product Rejection
The growing number of drug allergy cases and ineffectiveness of medication due to product contamination and low quality drug formulation are the biggest factors to diminish the customer loyalty and the brand image of the pharmaceutical company.
Results also show that frequent product recalls by pharmaceutical manufacturers have a significant negative impact on the pharmaceutical company resulting into the decrease in trust by healthcare and hospital professionals.
In the pharmaceutical business, the particle size distribution (PSD) of powder drug materials has turned out to be one of the pivotal aspects of drug product development and quality control of solid oral dosage forms. Furthermore, the PSDs of both drug material and excipients (also known as bulking agents, fillers or diluents) which facilitate drug absorption, enhance solubility and more can affect the final drug quality which, ultimately can impact safety, effectiveness, and quality of the drug product.
For solid oral dosage medicines, the impact of particle sizes of pharmaceutical powders on drug product quality is important and because of that the precise sizing and screening is required before drug formulation. For instance, the granulation and coating are interrelated to particle size enlargement, while milling and grinding are correlated to particle size reduction. Screening and sizing are associated with separation of particles with different sizes.
The right make of vibro sifter adhering to cGMP and US-FDA guidelines is important for pharmaceutical brands to achieve right sizing of powder material for their solid dose drug formulation. One of the important good manufacturing practices is to prevent and eliminate completely cross-contamination and bacterial contamination during formulation production process.
Now a day, for 100% screening of the product, the magnetic grills with the pre-defined gauss (magnetic) power is attached at the circular sifter outlet to further eliminate iron (ferrous particles) during the screening operation.
As a good manufacturing practice, even a 0.1mm iron particle detected in drug powder formulation, the material or the batch is rejected.
The magnetic grills or liquid magnetic filter is deployed or installed at sifter outlet and before syrup, liquid oral or vial filling to increase final drug quality respectively.
“The US-Food & Drug quality manufacturing standards state that “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.”
Therefore, the pharmaceutical machines are it vibrating sifters or self-cleaning filters with the right specifications are of utmost important in every manufacturing processes be it screening, sizing or filtration.
Talk to SIVTEK Solution Specialist and learn more how to increase quality of pharmaceutical API and Excipient with Galaxy Sivtek Vibro Sifters.
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