On Tuesday 23.08.2022, starting at 10:30 - Room H3.0 - Pharma innovation Stage
11:10 - The need for personnally administered parenterals is growing and so is the need for small batch packaging solutions that helps reduce their time to market.
Lars Skole Managing Director for LSS will discuss the emerging trends and challenges associated with growing parenteral drug packaging and labelling complexity and how pharmaceutical developers and manufacturers can meet the challenges ahead. And how, by the use of standard modular built labeling solutions, decrease the time to market for new products.
Device, vial and syringe labelling solutions customised to your packaging line. Standardised for your industry
How we made a high precision cartridge labelling solution with tolerances down to 0.2 mm
Beyond considerations around capacity, quality, delivery and price, this aspect of a machine purchase is probably the most significant selection factor beyond overall labelling performance and operating reliability.
Pharma’s equipment buyer’s require more assurances to implement new equipment into their production processes.
A lot of regulatory expectations have to be met before a new piece of equipment is qualified, commissioned and put into production in a pharma Current Good Manufacturing Practice (cGMP) environment.
Equipment qualification and validation is a basic authority requirements for equipment in the pharmaceutical and medical business. For being in compliance you will need to start with a Quality Activity Plan followed by Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute equipment qualification. You will receive a note of deficiency if you don't follows the authorities and legislation requirements and expectations to the mandatory validation documents starting with the Validation Master Plan.
To guide the process, the VMP defines the roles and responsibilities of the people involved in equipment qualification and directs compliance strategy. Included in this is the Equipment Validation Plan (VP) which may include more than one piece of equipment.
The list of equipment is appended to the plan. Each piece of equipment must have its own stream of documentation; this includes:
Regardless of the vendor, be sure that the vial labelling machine you select is documented for pharmaceutical application.
All of this documentation is necessary to commission equipment. Purchasing equipment from a labelling solutions provider without it is no solution - especially to pharma.
Although large pharma companies may have staff to support extensive equipment documentation to manage compliant equipment acquisition, a smaller company may not have the same resources to navigate machine commissioning without support.
That’s why vendor selection may be the most important factor to consider in making a labelling solution purchase decision. Those with specific experience and the expertise to know exactly what regulators need, as well as what they want to assure labelling capabilities and equipment are 100% compliant.
Contact us today for comprehensive labelling systems and vision inspection solutions ready to simplify the complexities associated with serializing and marking your pharmaceutical products.
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