Every manufacturer of pharmaceutical packaging has its own standard for what constitutes classification of non-conformities such as critical, major and minor defects. However, there are some situations in which clients require a higher level of quality.
At Namicos, we refer to this as a “quality gap” meaning that there is a gap between the quality of the packaging that the client is using and the actual quality they need.
Our Cleaning Processing and Visual Inspection service fills this quality gap while simultaneously increasing product yield and reducing drug product waste.
Cost Reduction
Cleaning Processing reduces our clients’ operating costs by eliminating their labor overhead and the costs associated with replacing and maintaining cleaning equipment. This is particularly true for small production batches, where it can be more efficient to outsource to Namicos.
Quality Risk
Cleaning Processing and Visual Inspection reduces the risk of product recall due to contamination. Clients may also benefit from a reduction in end-of-line product waste caused by packaging defects.
Packaging Quality Incident
Cleaning Processing and Visual Inspection helps clients tackle a sudden unexplained increase in defects (e.g. glass fragments) in their current packaging.
Quality as Strategy
Cleaning Processing and Visual Inspection increases the quality of drug packaging for the highest standards of patient safety.
Targeting New Markets
Some markets, such as Japan, require a higher level of visual quality, which is regarded as tantamount to safety. For this reason, Japan is regarded as having the most stringent requirements for appearance quality in the world. Cleaning Processing and Visual Inspection gives clients the ability to customize the quality of their preferred packaging.
Cleaning Processing and Visual Inspection is not a simple washing of containers. Instead, we transform your “raw material” (unwashed containers) into a clean and safe container with minimal appearance defects.
We do this through the meticulous minimization of contaminants, followed by a thorough visual inspection. With Namicos, you can be confident about the specifications of your containers, as the finished product is improved in quality from its original form.
Exploratory Inspection
For any new client, we offer an exploratory inspection to investigate the original quality of your glass or plastic containers. Historical data obtained by Namicos during more than 30 years of inspections reveal that, for many suppliers, we detect a high rate of appearance defects.
Custom Quality for Visual Inspection
After analyzing these data, we work closely to develop a custom quality standard for visual inspection. Our skilled inspectors can handle even the strictest quality requirements, and we offer solutions to suit every need.
Inspection of Packaging
The team at our Shiga Plant receive your unwashed containers (which we can source on your behalf). Our QA personnel make an initial inspection of the packaging.
The containers are processed and subsequently visually inspected in a highly clean environment (ISO 6/7 equivalent clean standards). During the inspection, our trained qualified inspectors remove any foreign matter and eliminate containers that fail to meet your quality standards.
For solid oral dosage forms or oral liquids, we offer a RTF (“ready to fill”) container that requires no further processing. For injectables, we deliver a particle-clean container with minimal appearance defects, offering you peace of mind and the opportunity to concentrate on your formulation.
Our Cleaning Processing service is registered with the FDA, DMF Type III, DMF Number 020667.
Namicos offers a variety of packaging-related products and services to reduce costs and accelerate speed-to-market for our clients.
See all our products & servicesSince its foundation in 1942, Namicos has played a major role in the pharmaceutical industry through the supply and manufacture of containers.
Based on our knowledge, technology and experiences, we have built a global network of suppliers and distributors who, together, help our clients meet their needs for quality and safety.
