Layer Explorer

Reliable and traceable instrument for measuring silicone oil distribution

Control lubrication in spray-on and baked-on siliconized containers

Features of the Siliconization Control Device

The Layer Explorer (LE) device determines the thickness and homogeneity of silicone oil layers for spray-on pre-filled syringes as well as baked-on cartridges and vials.

The robust Layer Explorer device determines the silicone oil layer quality parameters with ultra-high accuracy and reproducibility. The LE is notably successful in measuring baked-on silicone layers down to 20 nm thickness.

    • Easy, quick and reliable control of the thickness and distribution of the silicone oil layer before the filling process.
    • Discuss the quality of your pre-filled syringe lubrication with suppliers using valid data.
    • Ensure optimum homogeneous sliding friction forces for demanding auto-injector systems and reduce product loss from silicone interaction with protein based pharmaceuticals.
    • Highly accurate system ensures traceable standards, and thickness results are repeatable over months.
    • GxP ready and comes with the full equipment installation qualification documentation package.

 

 

The Layer Explorer in just 10 years, has become the gold standard of siliconization testing of pre-filled syringes. The system has been successfully validated by more than 30 international pharmaceutical and medical device manufacturers.

Several studies have shown that the inhomogeneous distribution of silicone oil in pre-filled syringes can promote the release of silicone oil droplets into the formulation. They can now be classified by the updated USP chapters USP <1790> and USP <1787> as intrinsic particles. Silicone oil droplets could induce aggregation of the proteins to form formulation-inherent protein particles.

Homogeneous distribution of silicone is a critical factor for the function of a pre-filled syringe and even more critical of an auto-injector cartridge. Holes in the silicone layer will result in a higher force displacement. The spring of an auto-injector could be insufficiently strong and the plunger could stop, causing a malfunction of the injection device. Control over the siliconization before filling can save precious product and minimize the chance of stability issues.

 

layer thickness
homogeneous distribution

Layer Explorer Characteristics and Applications

Basic Instruments (BI)

Layer Explorer features

Operation

    • Auto-focus controlled x, y, z ±10 µm-positioning on all axes
    • Sample holder for Ø 6 - 22 mm and 360° rotation
    • All measurement parameters can be pre-set in method files
    • 5 min/ sample (BI with 240 data points)

 

Ultra Thin (UT) Extrusion

GMP compliant

    • Software with user hierarchy and data storage 21 CFR Part 11 compliant
    • Traceable thickness standards for calibration and verification
    • IQ, OQ, and PQ documentation package
    • Computer system validation support and FAT and SAT testing procedures
    • On- and off-site application and validation support available

You are looking for -> Benefits

  • I want to know exactly what is going on with the silicone layer -

      •  Learn about µm sized droplets and visualize holes in the layer with high-resolution microscopic color images  
  • Your syringes have a diameter of 30 mm -

      • Large diameter sample holder option for up to 33 mm diameter available
  •  You want to show high resolution maps of you silicone layer -

      • Map the distribution of silicone layer with up to 7,200 data points/ measurements
  • You need a guarantee that the siliconization control works properly for you 24/7 - 

      • Global service, application support, and distribution 
  •  You would like to compare data from your 5 filling sites -

      • Profit from highly accurate and reproducible results
  • You won´t experiment with this quality relevant aspect of your product -

      • Rely on a 10-year-old matured technology and GMP ready software (pharmaceutical industry standard)

Traceable Standards and Reliable Results

Critical Quality Parameters

Tell good containers from bad containers before filling in your precious product. Syringe manufacturers ensure their product quality and establish quality parameters with their customers. In pharmaceutical manufacturing primary

packaging control delivers the valuable parameters for stability and homogeneity of the lubrication layer in bulk manufactured cartridges and nested pre-filled syringes.

Applications

 

Benefits

  • Provides inspection parameters for siliconization as a basis for discussions with suppliers
  • Reduces product loss resulting from silicone interaction with protein based pharmaceuticals
  • Friction force + stability
  • Ensures optimum homogeneous sliding friction forces for demanding auto-injector systems
  • Guarantees non-destructive measurement and preser-vation of the silicone layer for further analysis

 

Traceable Standard + Validation

 

The high accuracy of the system is ensured by certified traceable standards (Federal Seal), ensuring compliance with GMP and for worldwide standardized measurement results.

Superior Validation Data:

99% reproduceability on the scan line ±3% intermediate precision between 2 operators on 2 different days.

 

Silicone Heat Maps