Plunger Position Measuring System SPM

Plunger Position Measuring System:
Prediction tool for the behavior of the stopper in prefilled syringes and cartridges.

CFR 21 Part 11 compliant IT system

Meets all normative requirements
(GMP, FDA, ISO etc.)

The mobile Plunger Position Measuring System SPM from 3D innotec AG is used for automated inspection of the plunger movement in prefilled syringes and cartridges during transport at high altitudes by means of simulated pressure cycles.

The method of measuring syringe plunger movement, implemented using ASTM D6653/D6653M standard test methods, mimics the typical pressure buildup of a cargo jet during air freight shipments.

The transport of prefilled syringes and cartridges can cause expansion and contraction of the air bubble inside the syringe or cartridge due to the pressure difference at different altitudes. This can cause the syringe plunger to rise into non-sterile areas and possibly draw silicone and other contaminants into the product.

To address this potential risk to the sterility of the product, a system for recording the movement of the syringe plunger was developed.

Vorteile

  • Mobile unit
  • Low maintenance operation
  • System availability 24/7
  • User administration and user control of rights
  • Fixtures are designed and manufactured to customer and requirement specifications
  • High process reliability and process monitoring
  • CFR 21 Part 11 compliant IT system
  • PM-Control, PM-Quality and Audit-Trail integrated
  • Meets all normative requirements (GMP, FDA, ISO etc.)
  • Customer-specific adaptations are possible at any time

The Plunger Position Measuring System can simulate a negative pressure of up to -800 mbar over several pressure cycles lasting up to 9 hours. The plunger position is measured via images from the integrated and calibrated camera. By means of product specific fixtures, Up to 10 prefilled syringes can be measured simultaneously by means of product specific fixtures.

At the end of the simulation, the system automatically creates a test protocol. The pressure cycles and measuring times can be set and are stored in the device. This ensures that the same parameters are used for all measurements. Measurements are therefore reproducible and documented by the test protocol.

The mobile system can be seamlessly integrated into existing IT systems. The system is designed to comply with pharmaceutically relevant aspects, such as strict adherence to current GMP standards, the use of FDA-compliant construction materials, and the conformity of the IT system to CFR 21 Part 11 regulations.

On request, the system can be qualified by 3D innotec AG. The customer receives a complete documentation, which includes DQ, IQ, OQ, FAT and SAT protocols in addition to an operating manual and system description.

Technical data
  • Dimensions (lxbxh): 1109 x 789 x 1646 mm
  • Weight: approx. 250 kg
  • Height of working surface: 916 mm
  • Machine frame: Aluminium
  • Vacuum chamber, panelling: stainless steel 1.4301 (electropolished)
  • Vacuum chamber inside dimensions (lxbxh): 300 x 222 x 40 mm
  • Vacuum chamber temperature: 23°C ±2K (no active temperature control)
  • Vacuum chamber pressure: 0 bar…-0.8 bar atm. (0,2bar abs.) ± 0,005 bar (control deviation)
  • Max. time to pressure stability: -40mbar (-4kPa rel.) in 20s / -500mbar (-50kPa rel.) in 300s
  • Data recording interval : Parameterizable(0,1…1 measurements/s)
  • Camera system: KEYENCE – B/W Kamera with 16x speed and 21 Mpx
  • Camera measuring accuracy: ±0,1mm min.
  • Backlight: KEYENCE – white LED
  • Industrial PC (Computer): SIMATIC IPC477E; 16GB DDR4; 4xUSB; Ethernet; Win7/10; IP65
  • Control panel: 15 inch TFT touch 1280 x 800, incl. touch pen, rotatable and tiltable, signal light with alarm buzzer
  • Power supply: 230V~ / 0,1kVA (L/NL/PE); power cable (L=5m) type SEV1011/T12

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