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Aug 28, 2018 |
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ISO 11040 Testing Laboratory News

MET is expanding ISO 11040 and IS0 11608 laboratory testing capacity, to help address your pre-filled syringe regulatory requirements.

ISO 11040-8 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes. Forms part of two key series of standards which describe the performance and safety testing requirements for PFSs, prefilled pens (PFPs) and reusable insulin pens. Together these standards provide a clear description of the design verification studies for the combination devices both for novel and generic drugs.

ISO 11040-8 gives parameters for examining:

  • Biological safety
  • Break loose and extrusion forces
  • Break resistance
  • Burst resistance
  • Closure system forces and toques
  • Connectivity with fluid connectors
  • Container closure integrity
  • Deliverable volume
  • Drug container interaction
  • Liquid leakage beyond plunger
  • Needle penetration force
  • Needle pull-out force
  • Particle contamination 
  • Residual volume
  • Sharps protection performance

There is FDA Guidance for another section ISO 11040 -4. It also adds performance requirements for:

  • Accuracy of marking
  • Anti-needle-stick performance
  • Barrel neck curvature
  • Connectivity requirements given in ISO 80369
  • Coring needle test
  • Dead space
  • Dimensions to accommodate luer locks with a centre pin piercing element
  • Drug stability when considering physical attributes of the syringe
  • Effectiveness of reconstitution of drug / biologic when co-packaged
  • Height of the nozzle for a glass barrel syringe intended to connect to a Luer lock fitting
  • Human factors
  • Injection forces
  • Internal pressure required to release tip cap
  • Thickness of nozzle wall
  • Sterilisation
  • Syringe inner and outer diameter
  • Tip removal force

Many of these characteristics are described in other standards, some of which are listed here.

The remaining components of ISO 11040 are:

ISO 11040-1:

Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges

ISO 11040-2:

Prefilled syringes -- Part 2: Plunger stoppers for dental local anaesthetic cartridges

ISO 11040-3:

Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges

ISO 11040-4:

Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

ISO 11040-5:

Prefilled syringes -- Part 5: Plunger stoppers for injectables

ISO 11040-6:

Prefilled syringes -- Part 6: Plastic barrels for injectables

ISO 11040-7:

Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling

ISO 11040-8:

Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes

MET delivers design validation services for all of these standards and methods. Contact us about your project, you will find us really helpful.

Particle analysis USP 788            Dimensional analysis – FDA Guidance