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Pharma Reference Standards

M.A.S… prepares customized reference standard test kits for the visual inspection of paranterals and lyophilisates for the pharmaceutical industry. Each test set is prepared individually according the customer’s requirements and demands: Defined defects are added to the finished product.

The visual inspection of vials, syringes and ampoules is an important step in the production process of parenterals. Specific reference standards are required in order to determine the detection rate of defects during manual and automated visual inspections.

M.A.S… prepares upon request standard test kits for parenterals and lyophilisates with

M.A.S… prepares
  • Media Fill Reference Standards

M.A.S… offers
  • Validation and re-validation of reference test sets
  • Checks empty container for particles
  • Analysis of particles in finished products (Parenterals)

Each standard test kit comes with a detailed documentation. The measurement of particles and the analysis of other defects are done by validated digital image analysis.

Usage of Test Kits:

Quality control of automatic inspections
  • Validation of the inspection process
  • Inspection of the machine set up
  • Inspection following a format change

Quality control of manual inspections
  • Training for the testing staff
  • Qualification and re-qualification

Comparison of inspection methods
  • Manual vs. automatic
  • New products

Assessment of inspection processes
  • Functional testing at the beginning and end of a batch
  • Over a long period of time

For manufacturers of inspection machinery
  • Improvements
  • Redevelopment
  • New product / camera and tool setups

Crimping Machine: Bausch & Ströbel HV510

Visual Inspection: Seidenader VPE

Freeze Dryer: Martin Christ Alpha 2-4 LSC