Modular Platforms

Pharmpur has created a uniform platform consisting of individual modules which enable them to react quickly and flexibly to the changing requi­re­ments of contract manufac­turers. This is a precon­dition for manufac­turing numerous different niche products simul­ta­ne­ously while maintaining the same high quality level. All parties involved can thus profit from the associated rise in efficiency.

Process- and Product Families

Based on risk analyses and risk assess­ments, all similar processes and products that go through the same production process are catego­rised in families. This enables us to identify which “family members” represent the greatest challenge for process management. Quali­fi­cation and validation efforts can be signi­fi­cantly minimised via the corre­sponding Bracketing Approach.

Bracketing

Type of a study design by which the influence of variable parameters is deter­mined by assessing only those parameters’ extreme values previously identified via risk analysis; the result thereof is repre­sen­tative of the entire parameter-range applied.

Process Family

Catego­ri­sation of processes resulting in value creation by applying the same sets of parameters and resources (qualified personnel, devices, and equipment in suitable rooms).

Product Family

Catego­ri­sation of products whose production involves the same sequence of process families.

Customer-Specific Solutions

Customer-specific solutions for Fill & Finish tasks are effici­ently found by using the existing modules. This applies to improving upon existing product lines and to new develo­p­ments. Our new company building and facilities offer modern clean rooms enabling flexible production systems. A tailor-made zone concept fulfills inter­na­tional requi­re­ments to ensure a suitable production environment for manufac­turing orders.

Modular Processes

  • Positioning
  • Filling
  • Labelling
  • Packing

Platform Techno­logies

  • Nest filling of syringes, capsules and vials
  • Air bubble-free filling of highly-viscous media
  • Terminal steri­li­sation of tempe­rature-sensitive products
  • Compo­unding and handling of highly-viscous media

Document Templates

  • Speci­fi­ca­tions
  • Technical speci­fi­ca­tions
  • Master batch records
  • Certi­fi­ca­tions

Packaging Concept

The packaging processes at Pharmpur are a key element of our “everything under one roof“ concept and comprise both the packaging to ensure shell sterility (sterile bag, blister pack) and the product packaging (folding boxes). These packages are only offered as an element of the overall Fill & Finish processes.

  • Non-verbal infor­mation
  • Instruc­tions for use as leaflet or brochure
  • Forgery protection (tamper-evident)
  • Indivi­dua­li­sation through labelling
  • Shipping test
  • Material, dimension, artwork as modules