Bushu Pharma provides contract manufacturing of injectables, vials, lyophilized vial and
We can also handle ampoules and vials that require light shielding as a characteristic of injectables.
Inspection and Packaging Injectables
We inspect and package filled vials, syringes, and ampoules manufactured overseas. Our large refrigerated warehouse enables us to handle clinical samples and pharmaceutical products that require refrigeration.
Ensuring your product with no defects is essential to customers’ success in any markets. Bushu Pharma has strengthened its Inspection and analysis. We have the know-how, skillful inspectors, analysts and equipment to expertly conduct inspection and analysis of your product – checking for visual defects of both the product and packaging.
This function is a core part of our Bushu Pharma for injectables. Three key areas that are focused on to ensure all products meet quality requirements for the Japan market are:
1. Inspection of the cosmetic quality of bulk drug products
2. Inspection of the cosmetic quality of packaged products
3. Analysis for the presence of foreign materials
In order to meet market expectations for quality control in each of these areas, we employ the general following practices:
- Injectable products: foreign materials in filled vials and syringes manufactured overseas can be inspected by highly-trained operators to remove defects – such as small glass fragments and fibers – to meet Japanese market requirements.
- Finished products: the cosmetic quality of finished drug products can be inspected by well-trained operators who remove defects – such as dents or scratched carton boxes.
- Foreign materials: well experienced foreign analysis with various equipment, support process improvement and root cause analysis can be provided.
To implement the above inspection practices, we have highly-experienced inspectors who undergo an annual skill check and training, and we also feature the latest inspection technology – with an Automated Vial Visual Inspection machine installed in 2020 and a new Syringe Visual Inspection Machine set to be installed in 2021.
To support quality control in terms of foreign materials, we make quick response to market complaint and foreign matters found in manufacturing process. Both non-destructive and destructive analysis are available. Our knowledge and experiences of manufacturing is the practical approach the foreign materials from the results of analysis. As our representative scheme, we make Microscopic observation, Element analysis by X-ray Microscope, Identification by Raman, and Identification by FT-IR.