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10 steps for your custom controls

10-steps-for-your-custom-controls

RAW MATERIAL ACQUISITION

• In-house
• Sourcing

 QC TESTING

• Raw material incoming qualification

 FORMULATION

• Reagent formulation

QC TESTING

• In-process testing with designated analyzer

AUTOMATED FILLING

• Fill volume from 0.3 mL to 9 mL
• Autoadjustable filling pumps
• Accommodates vial sizes from 2 mL – 11mL
• Automated capping
• Capable of checking 100% dispensed solution by weight
• Vials placed in trays automatically
• Filling under HEPA filters
• In line stoppering

LYOPHILIZATION

• Hull 733 ft2
• Hull 220 ft2
• Pennwalt Stokes 120 ft2
• Pennwalt Stokes 72 ft2
• Hull 36 ft2

FINAL PRODUCT TESTING

• Karl Fisher
• Moisture Analysis
• Homogeneity testing between vials
• Bioburden
• Stability
• Value assignment

LABELLING

• Based on internal specifications or per customer requirement

PACKAGING

• Ready for end user or Bulk for further processing by customer

FULFILLMENT

• Distribution

»DOWNLOAD THE 10 STEPS FOR YOUR CUSTOM CONTROLS!«