Pharmaceutical & Nutraceutical Packaging Lines

Issues to resolve before machine selection

Each risk should be converted into a design requirement, a trial, an operating control or an explicitly accepted limitation. Product and component samples should represent the difficult extremes rather than only a nominal production format.

• 1
  Cross-contamination and cleaning verification

  Assess the likelihood, production effect and design or operating control before the line is ordered.

• 2
  Dose variation at the operating extremes

  Assess the likelihood, production effect and design or operating control before the line is ordered.

• 3
  Mix-ups between components, labels and recipes

  Assess the likelihood, production effect and design or operating control before the line is ordered.

• 4
  Documentation, audit trail and change control needs

  Assess the likelihood, production effect and design or operating control before the line is ordered.

Application brief checklist

Send the following information with the initial enquiry. Early clarity usually shortens the route to a credible line concept and makes quotations easier to compare.

• User requirement specification and risk assessment
• Dose range, tolerance and test method
• Product-contact materials and cleanability
• Batch, recipe and data requirements
• Label verification and reject controls
• FAT, SAT and qualification responsibilities

Testing and production handover

Agree the factory and site test materials, run duration, quality checks, required good output and treatment of interruptions. Training should cover safe startup, shutdown, replenishment, changeover, cleaning, first-off approval and basic fault response.