Cytotoxic compounds are mainly utilized in oncology to treat cancerous cells; however, these substances present unique environmental and safety issues because of their highly toxic nature. As a result of these challenges, cytotoxic drugs must be packed safely and securely as even the smallest amount of exposure can pose a major threat to the human body.
These hazards in turn have increased the demand for packaging facilities which package these drugs correctly, conform to industry regulations, and also consider the safety of the environment and the welfare of those packaging them. This article explores how Packaging Coordinators, Inc. (PCI) has utilized its know-how to develop a specialist facility which is fully compliant with industry regulations.
Cytotoxic Drugs for Cancer Treatment
Cytotoxic drugs are substances that are often employed for treating cancers as part of chemotherapy treatment. Lately, these drugs are being used in a number of applications such as for the treatment of steroid-resistant muscle conditions, rheumatoid and juvenile rheumatoid arthritis, and certain skin conditions.
Although cytotoxic compounds are important, they contain extremely hazardous pharmaceutical substances that are known to have mutagenic, genotoxic, mutagenic and carcinogenic potential. Therefore, special precautions must be adopted to handle and package these products so as to reduce risk to human health and the environment.
Proper provisions would comprise packaging products in solid materials that are hermetically sealed and hence ensure sufficient protection. Also, labels should be fixed on vials, containers and boxes to indicate that the packaged substance is a cytotoxic drug. Other Information like proper storage instructions, how the products should be handled, expiry dates, etc. must also be included.
In order to reduce possible safety issues, cytotoxic drugs must be stored away from other pharmaceuticals and only trained workers using protective equipment must be allowed to handle these substances.
The Challenge: Building a Dedicated Facility
A European pharmaceutical company that manufactures cytotoxic drugs enlisted the help of PCI for a suitable packaging solution. Prior to this the client lacked the capability to pack these types of pharmaceuticals in a safe and stable environment, with regard to safety issues and industry regulations. In response, PCI devoted a considerable amount of time and investment to set up a new dedicated facility, which is geographically isolated from the main operations building, to accommodate the packaging of these toxic substances.
The entire process proved very challenging and necessitated the implementation of rigorous safety measures to produce a fully compliant operating facility. When cytotoxic pharmaceuticals are used, it is necessary to ensure that suitable safety procedures are defined and incorporated into the process all through the stages, including packaging operations.
The main concern throughout the phase of this project was to ensure the safety of the drug and the staff handling the products, and a large part of the design was centered on operator comfort, design of personal protective equipment, and suit design. It was also deemed that a specially trained team would operate the new site; this team would have the required expertise to handle these substances.
Within a few months, a fully validated and regulatory compliant facility was built by PCI that was designed to guarantee the safe packaging of cytotoxics, as well as the comfort and safety of the company’s staff and the surrounding environment. Since completion, the facility has been utilized for safe and effective packing of these drugs into thermo formed vitrapacks.
In order to optimize the project, two experienced PCI project managers were deployed to supervise the entire process. Under their guidance, the building of the new site was closely monitored by a fully trained operational team, who were simultaneously being trained on the particular requirements related to packing and handling cytotoxic compounds.
The project was concluded within a short time frame and budget, and as a result the final packaged drug was introduced into the market earlier than anticipated. Both the processes and quality materials utilized throughout the project were able to fulfill the client’s expectations.
PCI’s expertise in packaging substrate technology enabled it to deliver novel packaging solutions that integrate security, regulatory compliance and patient-friendliness. Moreover, all solutions comply with pharmaceutical artwork regulations and consider the significance of both human health and the environment.
PCI is one among the few contract packaging services in the UK that offers the capability to safely pack cytotoxic compounds. The new operational unit has provided PCI with a distinct competitive advantage, enabling the company to deliver holistic services worldwide.
Produced from articles authored by Dr. Sue Miles, UK Site Director, PCI
About Packaging Coordinators, Inc.
Packaging Coordinators, Inc. (PCI) specializes in providing packaging solutions to the global healthcare industries that need to increase their products’ speed to market for commercial success. PCI brings the proven experience that comes with over 50 successful product launches a year and more than 40 years in the healthcare business. Continued investment and leading technology allows PCI to meet global packaging needs throughout the product life cycle - from Phase I clinical trials through commercialization and ongoing supply. PCI’s clients view the company as an extension of their business and a collaborative partner, with the common goal of improving patients’ lives.
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