Abstract

PROCESS VALIDATION OF BLISTER PACKAGING LINE OF RISPERIDONE TABLETS

Akash Gupta*, Dr. Nimita Manocha and Dr. Vimukta Sharma

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Abstract

The blister packaging is unique for tablets and capsules in many ways. In blister packaging tablets and capsules can be packed in very controlled way. Tablets of rigid and fixed size are placed into a rigid cavity and flexible lid material is stamped over it to complete the package. Tablet lines can generally handle product with relentless consistency, therefore making defects very rare. An interesting aspect to the blister package is that although each cavity is separate, it is also dependent. If the seal between two cavities is breached, it does not compromise the sterility or quality of the product, unless one of the blister cavities has a leak to the outside of the package. With today’s new drug delivery systems, certain drugs are extremely sensitive to moisture. In these cases, within minutes of being subjected to normal room temperature and humidity conditions, the drug delivery becomes ineffective. Blister packs comply with Leak test and Blister quality and were found to be satisfactory as per IH specifications at the speed of 20 cuts/minute and the specified forming and sealing temperatures. At specified machine speed i.e. 20 cuts/minute and specified forming & sealing temperature, the blister packs formed comply with the specified limits mentioned in protocol and this speed is considered as validated.

Keywords: Process Validation, Blister Packaging, Risperidone, GMP, USFDA.