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Home / Products / Capsule Counting Machine / SUS316L Capsule Counting Machine 21 CFR Part 11 Automatic Pill Counter 16 Channel
Quality SUS316L Capsule Counting Machine 21 CFR Part 11 Automatic Pill Counter 16 Channel factory
Quality SUS316L Capsule Counting Machine 21 CFR Part 11 Automatic Pill Counter 16 Channel factory

SUS316L Capsule Counting Machine 21 CFR Part 11 Automatic Pill Counter 16 Channel

Basic Properties
Place of Origin: Shanghai,China
Brand Name: TIWIN INDUSTRY
Certification: CE
Model Number: TW-16B
Trading Properties
Minimum Order Quantity: 1 Set
Payment Terms: T/T
Supply Ability: 30 Sets per Month
Tags

pill counting machine

tablet counting machine

automated pill counter
Product Summary
GMP and 21 CFR Part 11 compliant 16 channel machine vision capsule counting system with full SUS316L product-contact construction. Features automated smart rejection for over-count, under-count, overlapped, and fragmented products. Electronic batch records and audit trail capability make it ideal for regulated pharmaceutical manufacturing environments.

Product Details

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SUS316L Capsule Counting Machine

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Capsule Counting Machine 21 CFR

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16 Channel automatic pill counter
Model: 16 Channels
Capacity: 60 Bottles/min (100pcs Per Bottle)
Filling Range: 1-9999 Pcs
Material: SUS316L Contact Parts, SUS304 Body
Machine Dimension: 1900x1800x1750mm
Filling Precision: By Visual Inspection
Maintenance: Easy Maintenance With Modular Design
Customizationoptions: Available Based On Product And Packaging Requirements
Userinterface: Touchscreen HMI
Industry: Pharmaceutical,food,nutrition
Powersupply: 220V/380V, 50Hz/60Hz
Afrer Sale Service: 24hours In 7 Days Online Support
Product Description
GMP 21 CFR Part 11 Compliant Machine Vision Capsule Counting System
GMP 21 CFR Part 11 Compliant Machine Vision Capsule Counting System 16 Channel SUS316L for Pharmaceutical Production

Engineered for regulated pharmaceutical manufacturing environments, this 16 channel machine vision counting system meets GMP requirements and 21 CFR Part 11 compliance for electronic records. Full SUS316L stainless steel construction on all product-contact surfaces ensures the highest hygiene and cleanability standards. Integrated smart rejection automatically diverts any non-compliant bottle, safeguarding batch quality for every production run.

Technical Specifications
Model TW-16B
Suitable for Bottle Type 10-500ml round or square bottles
Suitable for Product Thickness 3-30mm, Diameter 1-30mm, Length 2-45mm
Capacity 60 bottles/min (100pcs per bottle)
Filling Quantity Range 1-9999
Air Consumption 0.6Mpa
Voltage 220V/1P, 50Hz
Power 1.6KW
Machine Dimension 1,900 x 1,800 x 1,750mm
Net Weight 560kg
Regulatory Compliance & Quality Assurance
21 CFR Part 11 Electronic Records Compliance
  • Full electronic batch record (EBR) generation with time-stamped audit trails
  • Password-protected user access levels (Operator, Supervisor, Administrator)
  • All production parameters logged: count per bottle, rejection events, operator ID, batch number
  • Data export via USB for regulatory submission and quality review
  • Tamper-evident electronic signatures for batch approval workflows
Premium Material Construction
  • All product-contact components fabricated from pharmaceutical-grade SUS316L stainless steel
  • Outer body and frame constructed from SUS304 stainless steel for durability and easy sanitation
  • Seamless weld construction eliminates particle traps and facilitates validated cleaning procedures
  • Three-stage built-in dust extraction system prevents cross-contamination between production batches
  • 300mm optimal camera distance significantly reduces dust adhesion on lens surface
Smart Quality Control & Rejection
  • Automated rejection of bottles with over-count, under-count, overlapped products, or fragmented pieces
  • Real-time reject statistics displayed on HMI for immediate quality trend analysis
  • High-speed industrial camera with dynamic scanning detects broken tablets at full production speed
  • 99.99% counting accuracy validated per pharmaceutical cGMP guidelines
  • Self-diagnostics with fault detection and visual/audible alarm notification
Operator-Friendly Design
  • Intuitive touchscreen HMI with English/Chinese multi-language support
  • Built-in motorized lifting mechanism for rapid bottle format changeover
  • Quick-release components for efficient cleaning and line clearance between batches
  • CE certified with comprehensive documentation package for international regulatory filing
FAQ - GMP Compliant Counting
Q: How does 21 CFR Part 11 compliance work in this counting system?
The system maintains electronic records with secure, computer-generated, time-stamped audit trails. User access is role-based (Operator/Supervisor/Administrator) with password protection. All counting data, rejection events, and parameter changes are logged and exportable for regulatory inspections and batch release documentation.
Q: Why SUS316L instead of SUS304 for contact parts?
SUS316L contains molybdenum which provides superior corrosion resistance against acidic pharmaceutical formulations and cleaning agents. It is the preferred material for GMP-compliant pharmaceutical equipment where product-contact surfaces must withstand aggressive CIP (Clean-in-Place) protocols without degradation.
Q: Can the smart rejection system be validated?
Yes. The rejection system includes a verification mode for IQ/OQ/PQ validation protocols. Known-defect challenge tests (over-count, under-count, fragment) can be documented as part of equipment qualification, and the rejection accuracy log is included in the electronic batch record.

Miss. Toi Foo

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