Capsules for injectable products: innovation and safety

Specialized manufacturer of closure systems for pharmaceutical pack-aging, Capsulit focuses on Top Cap injectable capsules: available in dif-ferent variants, they guarantee product integrity as well as a safe and practical experience for the patient.

They have different diameters, shapes and heights, defined according to the size according to ISO standards and can be entirely in aluminum, plastic, or in aluminum and plastic. Called Top Cap, Capsulit capsules for injections are produced in three distinct technological phases: shearing of the ring nut starting from aluminum coil, molding of the plastic disk through an injection process in multi-cavity molds, assembly of the two components using high-speed automatic machines.

Thanks to the insulation of the machines from the surrounding environment, the whole process offers the maximum guarantees of quality and hygiene, while sophisticated vision systems ensure the quality of the production 100%, with the expulsion of any defective parts.

Constantly monitored by state-of-the-art automatic systems, the processes are therefore connected online with the company’s IT system: according to the logic of Industry 4.0, in this way, the progress of orders is always under strict control. Capsulit’s goal is therefore to offer the pharmaceutical industry a proven and constant quality product, to the advantage of the overall efficiency of the filling and closing lines (perfected over time to be ever more performing): the use of capsules produced according to high quality standards, combined with the punctual checks of the entire production process, in fact guarantee stable crimping performance, minimizing the risk of line interruptions and downtime.

Top Cap, in different versions

Variable in diameter, shape and size, as mentioned at the beginning, the Top Cap capsules can also have different coupling systems between the two components, designed for easy opening and, at the same time, to guaran-tee the inviolability of the package.

All variants are also customizable with engraved or printed brands with autoclavable colors.

The Top Cap can be produced and packaged in the RTS (ready to sterilize) version, therefore ready to undergo gamma and beta sterilization treatment, or in an autoclave using processes validated according to ISO 11137.

The closures for gamma or beta treatment are packed in double low density polyethylene bags, heat-sealed according to Capsulit specifications or ac-cording to specifications agreed with the customer. Studies carried out on the packaging guarantee their tightness - and therefore the sterility of the contents - for a period of at least three years.

The closures intended for autoclave treatment at 121 ° C for 30’ are instead packed in special heat-sealed Tyvek or Stericlean bags. The capsules can also be supplied in RTU (ready to use) version treated with gamma rays by specialized partner companies, with a minimum level of 25.0 kGy through processes validated according to the ISO 11137 standard aimed at guaranteeing a sterility level of 10- 6.

Each batch of RTU closures is accompanied by a treatment certificate issued by the partner company, which carries it out according to validated processes and in accordance with the agreed specifications. At the customer’s request, a representative sample of the batch can be subjected to sterility tests performed by an external laboratory, which guarantees its compliance by issuing a relative certificate.

On samples of capsules representative of the batches produced, Capsulit periodically checks the microbial load (bioburden) and dose audits, to verify over time the validity of the initial validation according to ISO 11137.