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LSS will attend the Achema PRAXISforum within Pharmaceuticals, Packaging and Storage techniques topic.

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.

Download here our latest trend ebook here to find out how you can tackle drug labelling's increasing complexity  


Made to measure device, vial and syringe labelling solutions that meet your standards. 

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

Click here to get access to the full video and case story

 

Regulatory factors to consider before purchasing a vial labelling machine 

 

Among the top considerations when selecting a vial labelling machine for use in a pharmaceutical manufacturing environment is how well it supports overall regulatory compliance.


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.

Seek solutions intended for pharma applications

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

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:

  • User Requirement Specifications
  • Design Qualifications
  • Risk Assessment
  • Installation Qualifications
  • Operational Qualifications incl. Process Validation
  • Performance Qualifications

Be sure equipment is validation and audit ready

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. 

If you would like to know more about how our vial and ampule labeling solutions, find our labelling solutions guide her

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Would you like to know more about our solutions for the pharmaceutical industry?

Contact our experts

Søren Andersen
Søren AndersenProject Sales Manager+45 2373 3901 See LinkedIn profile
Jan Vinther
Jan VintherProject Sales Manager+45 8711 0809 See LinkedIn profile
Frank  Qvortrup Thygesen
Frank Qvortrup ThygesenProject Sales Manager+45 8711 0811 See LinkedIn profile
Peter B. Hansen
Peter B. HansenProject Sales Manager+45 8711 0824 See LinkedIn profile