Pharmaceutical Packaging & Legislation
Pharmaceutical product deliveries carry a unique set of risks; shipments must arrive on time, intact and in many cases with controlled temperatures.
With the premises set out above, pharmaceutical packaging must be able to be made with materials and closure systems that excellently ensure the precious content which, in some cases, is of vital importance.
The legislation for pharmaceutical products assigns a very important role to water-activated gummed paper tape (WAT).
Packaging and sealing tapes play a dominant role in meeting two important legal provisions for the European pharmaceutical industry: the Directive on medicines to protect against possible fakes (2011/62 / EU) and the related Commission Delegated Regulation (EU) 2016 / 161.
In particular, the gummed paper tape perfectly satisfies some specific requirements of the above standards.
These legal provisions provide details on how and by whom the authenticity of medicines should be verified, as well as the characteristics of the safety devices applied for closure.
An important element includes the use of tamper-proof sealed packaging to prevent “fake” or non-compliant medicines from entering the legal supply chain. It is estimated that around 38 billion packages of medicines are sold and managed in Europe each year.
CEN EN 16679/2014: “Tamper verification characteristics for drug packaging”, serves to define the characteristics used for handling verification. These characteristics should indicate that the outer packaging of a finished product has been opened or tampered with in order to prevent the unnoticed entry of “fake” or non-compliant medicines.
In fact, the standard describes the scope, requirements and characteristics of tamper-proof pharmaceutical packages and provides specific recommendations for adequate sealing.
WAT gummed paper tape is the most appropriate sealing method to meet these requirements.
The use of WAT provides the packaging with safety closure and informs the recipient of possible tampering during transport; once applied, the WAT tape “melts” with the packaging creating an alteration-proof seal. A carton sealed with WAT cannot be opened without leaving a broken seal.
Wondering if WAT tape can help your organization make your product shipments safer? Contact us, we will be happy to tell you about our experiences in the field and ways to satisfy your requests.