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Schaffhauserstrasse 30 - 4332 Stein - Schweiz
+41 56 281 91 14
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Switzerland, Stein AG - 4332
Schaffhauserstrasse 30

+41 56 281 91 14

info@qps-engineering.ch

Call us: +41 56 281 91 14
Address: Schaffhauserstrasse 30 - 4332 Stein - Schweiz
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Defect Imitation Testset – Lyo Vials

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Defect Imitation Testset - Lyo Vials
Defect Imitation Testset - Lyo Vials - Image 2
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Enhance your quality control processes with QLabs’ Premium Defect Simulation Test Kit. Specifically designed for pharmaceutical, biotechnology, and food technology industries, this comprehensive kit includes pre-filled glass vials featuring realistic defects such as cracks, holes, dust particles, and metal shavings. Ideal for calibrating and validating Manual, Semi-Automated, and Automated Visual Inspection systems, our test kit ensures accurate defect detection, improves inspection efficiency, and supports regulatory compliance. Trust QLabs to provide the precision tools you need for superior quality assurance.

SKU: 12564789-20-2
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Lyophilized Vials (Lyo-Vials)

This category features specially prepared, freeze-dried samples. The goal is to train personnel in recognizing typical quality and handling defects in the lyophilizate and vial body.

  • Foreign Particles in the Lyo Cake: Metal or glass inclusions in the porous cake train the identification of contamination.
  • Stress Cracks in the Glass: Fine cracks or scratches on the outer glass surface simulate microscopic glass defects that are easily overlooked in routine inspections.
  • Closure Defects and Leaks: Defective or loosely inserted rubber stoppers teach proper stopper handling and the detection of sealing issues.
  • Stopper Damage: Cracks, cuts, and abrasion on the rubber stopper demonstrate various defect types that can lead to product loss or contamination.
Key Advantage Description
Standardization of Inspection Predefined defect types in lyophilized products (e.g., particles in the cake, cracked vials) ensure consistent inspection standards, reducing subjective interpretation and increasing reproducibility.
Validation and Qualification of Inspection Stations Known defect samples allow calibration and verification of magnification, lighting, and operator accuracy. Microcracks and embedded particles simulate real production challenges.
Training and Competency Verification Standardized freeze-dried defect vials ensure training consistency and performance testing for new staff. Repeated tests confirm detection capability over time.
Ongoing Performance Monitoring Routine use of test vials documents the effectiveness of visual inspection and provides traceable performance records to detect skill drift or system degradation.
Reduction of False Rejects and Missed Defects Precise definition of critical defect types improves decision-making accuracy, reducing unnecessary rejections while safeguarding against undetected product risks.
Regulatory Evidence Training and qualification data using Lyo-Vials serve as documented proof for GMP compliance during audits, satisfying FDA, EMA, and global regulatory expectations.
Weight 1 kg
Dimensions 10 × 11 × 22 cm

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