Frequently Asked Questions On Quality Testing Of Medicinal Hollow Capsules

What is the main focus of quality control for hollow capsules?

The quality control of hollow capsules depends on the raw materials, gel solution, film-forming, drying, fitting, testing, packaging, and release documents. For customers, the appearance of a single sample is only a part of it, COA, Batch inspection reports, batch number traceability, sample testing, and supplier audit documentation are equally important.

Why do pharmaceutical hollow capsule manufacturers need to check CDE registration information?

The medicinal project will pay attention to the registration information of the original auxiliary package. CDE registration information cannot replace the COA of a certain batch of products, nor can it replace the customer's own supplier audit, but it is a common basic check item for the evaluation, data archiving, and project initiation of pharmaceutical hollow capsule manufacturers.

What is the difference between COA and batch inspection report?

COA mainly indicates whether the inspection items and results of a certain batch of products meet the agreed standards; Batch inspection reports usually contain more detailed testing data, methods, and judgment criteria. Both are important, but neither can replace long-term quality system audits of suppliers.

Is it necessarily an empty capsule problem if the capsule cannot be opened or locked abnormally on the machine?

Not necessarily. Failure to open the bag, falling off the cap, improper locking, and increased rejection may be related to pre locking of the empty bag, moisture, size, as well as the vacuum of the filling machine, mold holes, speed, filling volume, residual powder at the body opening, and on-site temperature and humidity. When troubleshooting, the abnormal workstation should be located first, and then judged based on the batch number, sample, and on-site records.

What is the difference in quality control between gelatin hollow capsules and HPMC hollow capsules?

The material sources, moisture properties, content compatibility, and stability concerns of gelatin hollow capsules and HPMC hollow capsules are different. The gelatin hollow capsule technology is mature and suitable for a large number of conventional projects; HPMC hollow capsules are commonly used in some plant-based, low moisture, or moisture sensitive formulations. The specific selection should be judged based on the content, packaging, target market, and sample results.

What quality concerns will customized color capsules and printing capsules add?

Customized color capsules should pay attention to color consistency, shading materials, color difference, and batch stability; Printing capsules should pay attention to printing clarity, reprinting, omission, consistency of position, and recognition effect. For serialized products, color and printing not only affect appearance, but also impact anti confusion and brand recognition.