GMP Pre-Syringe Vision Inspection Machine is designed for automated quality control of prefilled syringes in pharmaceutical production. The high-precision vision inspection system detects defects such as particles, filling level, syringe components, labeling, and packaging issues. Ideal for GMP-compliant pharmaceutical manufacturing, injectable drug production, and automated prefilled syringe inspection lines.<\/p>\n
1.1 Needle\/Bottle Inspection<\/p>\n
Dimensional Accuracy: Inner and outer diameters (accuracy \u00b10.002mm), length, needle tip taper (\u00b10.1\u00b0), straightness (\u00b10.01mm\/m), concentricity (\u00b10.005mm). Appearance Defects: Burrs, barbs, microcracks, bends, blockages, flat needle tip, abnormal blade proportions.<\/p>\n
1.2 Syringe Inspection<\/p>\n
Appearance Flaws: Black spots, scratches, bubbles, stains, hair, deformation, cracks. Printing Quality: Missing graduations, skewed markings, blurry printing, unclear logo\/characters, misregistration. Assembly Status: Insufficient glue on the pin holder, excess glue, assembly misalignment, missing\/damaged protective sleeve.<\/p>\n
1.3 Plug\/Core Rod Inspection<\/p>\n
Plug Defects: Deformation, damage, insufficient material, misaligned sealing ring, misaligned locking mechanism, 360\u00b0 surface defects. Core Rod Status: Missing, bent, cracked, incomplete push-in, abnormal color.<\/p>\n
1.4 Finished Product and Packaging Inspection<\/p>\n
Assembly Defects: Missing parts, assembly errors, poor sealing, foreign matter contamination (\u226530\u03bcm). Packaging Inspection: Missing parts in bags\/boxes, poor sealing, blurry coding, and missing printing.<\/p>\n
2.1. Working Principle<\/p>\n
The system employs a \u201cmulti-source imaging + high-definition image acquisition + AI deep learning algorithm\u201d solution:<\/p>\n
Customized light sources (backlight\/ring\/coaxial) highlight the contrast of defects in transparent\/reflective parts; High-resolution industrial cameras (5MP \u2013 20MP) acquire images in milliseconds; AI algorithms analyze in real time, identifying defect type, size, and location, and automatically sorting NG\/OK products.<\/p>\n
2.2. Core Hardware<\/p>\n
Imaging Unit: 5MP area array CCD (120fps) \/ 20MP line array camera, dual telecentric lenses (5X magnification), high-uniformity multispectral light source. Mechanical Unit: Precision rotating fixture (runout \u22640.002mm), pneumatic feeding\/sorting, servo conveyor line, 360\u00b0 inspection station. Software Unit: Customized vision algorithm library, AI defect model, data traceability system, human-machine interface.<\/p>\n
3.1 Detection Accuracy: Size \u00b10.002~\u00b10.005mm; Defect identification \u226530\u03bcm, accuracy 99.9%+. 3.2 Detection Speed: 30~200pcs\/min (customizable), supports online full inspection on high-speed production lines. 3.3 False Detection\/Missed Detection Rate: False detection <0.1%, missed detection \u22480, far superior to manual detection (95%~98% accuracy). 3.4 Changeover Time: \u22645 minutes, compatible with 1ml~50ml syringes of all sizes. 3.5 Traceability: Automatically stores detection data, images, and batch information, meeting GMP data integrity requirements.<\/p>\n
1.Micron-Level High Precision: Breaks the 50\u03bcm limit of the human eye, stably identifies 30\u03bcm-level micro-defects, eliminating the risk of missed detection.<\/p>\n
These features ensure the product remains sterile, unadulterated, and consistent from the first bottle to the last. Material Compatibility:<\/p>\n
1.1 Product-contact parts must be made of AISI 316L stainless steel, medical-grade silicone, or FDA-approved plastics to prevent chemical leaching and corrosion. 1.2 Sanitary Design: Machines require smooth surfaces, minimal crevices, and tri-clamp connections to eliminate areas where bacteria can grow. 1.3 CIP\/SIP Capabilities: Clean-in-Place (CIP) and Sterilization-in-Place (SIP) systems allow automated cleaning and steaming of fluid pathways without dismantling the machine. 1.4 Laminar Airflow & Isolation: RABS (Restricted Access Barrier Systems) or Isolators supply HEPA-filtered air to maintain a sterile zone over the open containers. 1.5 Drip and Splash Controls: Anti-drip nozzles and diving nozzles (which lower into the bottle during filling) prevent product from spilling onto the container rims, which could ruin the cap seal.<\/p>\n
These features protect the workers operating the line and prevent catastrophic machine damage.<\/p>\n
2.1 Interlocked Physical Enclosures: Transparent polycarbonate or tempered glass doors prevent operators from reaching into moving parts. Opening a door instantly cuts power to the moving components. 2.2 Emergency Stop (E-Stop) Buttons: Highly visible, mushroom-headed buttons must be placed at multiple accessible points around the machine to halt operations immediately. 2.3 Capping Torque Control: Magnetic clutches or servo-driven capping heads prevent over-torqueing (which can shatter glass or strip plastic caps) and under-torqueing (which causes leaks). 2.4 Low Noise Levels: Sound-dampening enclosures keep noise levels below OSHA-mandated limits (usually under 85 dBA), especially around noisy cap-sorting bowls.<\/p>\n
GMP requires strict verification to ensure that every container leaves the line correctly filled and sealed.<\/p>\n
3.1 Weight & Fill Verification: In-line checkweighers or vision systems instantly reject under-filled or over-filled containers without stopping the line. 3.2 Cap Detection Systems: Vision sensors detect missing, crooked, or high caps, automatically pushing faulty products to a rejection tray. 3.3 Audit Trails & 21 CFR Part 11: For pharmaceuticals, the machine\u2019s software must track all operator logins, setting changes, and alarms in a secure, unalterable electronic log.<\/p>\n
Shanghai Reliance Machinery Co., Ltd.\u00a0is a professional manufacturer of pharmaceutical liquid filling and packaging equipment, providing complete turnkey solutions for sterile liquid production.<\/p>\n
01 DESCRIPTION 1. Core Inspection Scope (Full Component Coverage) 2. Technical Principles and Hardware Configuration 3. Key Performance Indicators<\/p>\n
02 FEATURE<\/p>\n
03 FAQ<\/p>\n
04 GMP & SAFTY 1.Product Protection & Contamination Control (GMP) 2. Operator Safety & Machine Protection 3. Data Integrity & Quality Control<\/p>\n
1.Product Protection & Contamination Control (GMP)<\/p>\n
05 WHY RELIANCE<\/p>","protected":false},"excerpt":{"rendered":"
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