Vision Inspection · Flip-Off Seal

FOSIS — Flip-Off Seal Inspection System

600 caps/min
18+ Defects
21 CFR Part 11
5 Seal Sizes
100% Inspection
FOSIS Flip-Off Seal Inspection System

Why Flip-Off Seal Inspection Matters

18+

Defect types detected across 3 zones for comprehensive quality assurance

100%

Automatic inspection with zero manual intervention required

21 CFR

Full FDA compliance for pharmaceutical manufacturing standards

Flip-Off Seal Inspection System

FOSIS Machine
Flip-Off Seal Close-up Flip-Off Seals with Bottles

What is a Flip-Off Seal?

A flip-off seal is a tamper-evident closure mechanism used in pharmaceutical packaging. It consists of an aluminium shell that covers and protects the product, with a button designed to be flipped off to access the contents. These seals are critical for maintaining product integrity, sterility, and compliance.

How FOSIS Works

FOSIS uses advanced machine vision and AI deep learning to inspect flip-off seals at high speed. The system automatically detects defects across three zones: the outer aluminium shell, inner surface, and PP button. Defective items are instantly ejected using pneumatic ejection, ensuring 100% quality control.

Up to 600 caps/min
Vibratory SS304 Feeder
21" Touchscreen Display
AI Deep Learning

Flip-Off Seal Sizes

13mm
Diameter: 15mm
Height: 8mm
Standard size
20mm
Diameter: 22mm
Height: 8mm
Mid-range
28mm
Diameter: 31mm
Height: 11mm
Large vials
32mm
Diameter: 36mm
Height: 16mm
Extra large
34mm
Diameter: 36mm
Height: 14mm
Premium

18+ Defects Detected Across 3 Zones

Zone 1: Outer Aluminium Shell

  • Cuts on aluminium shell
  • Wrinkles on shell surface
  • Strain marks outside shell
  • Deformation / bends
  • Aluminium shell missing
  • Ring not separating from shell
  • Gap when mixed cap diameter comes

Zone 2: Inner Surface

  • Black marks
  • Dent marks
  • Dirt & dust
  • Improper crimped seals
  • Inter-mix of shell (wrong shell in batch)

Zone 3: PP Button

  • Horizontal & vertical flash
  • Short fill
  • Black spots
  • Colour shade variation
  • Cut on PP button
  • Plastic cap missing

FOSIS Software Interface & Operator Display

FOSIS Operator Display — Last 100 Defects with Images
FOSIS Operator Display

FOSIS technical specifications

Key figures from the FOSIS brochure for flip-off seal inspection.

FOSIS technical specifications
ModelOptomech FOSIS (Flip-Off Seal Inspection System)
SoftwareProprietary user-friendly software, 21 CFR Part 11 compliant
User interface21″ touch screen graphical user interface
Products inspectedFlip-off seals: Ø15 × 8 mm (13 mm), Ø22 × 8 mm (20 mm), Ø31 × 11 mm (28 mm), Ø36 × 16 mm (32 mm), Ø36 × 14 mm (34 mm)
SpeedUp to 600 caps/min (13 mm)
Defects detectedShort fill, black spots, colour shade, cut on PP button, cut on aluminium shell, wrinkles, black marks, strain marks, dent marks, dirt and dust, deformation/bends, improper seal, missing seal, ring missing, plastic cap missing, intermix of shell, gaps between caps
Machine size (approx.)L 2300 mm × W 750 mm × H 1530 mm; weight 150 kg
ConveyorsMain: belt width 40 mm, length 1800 mm
Conveyor 2: belt width 40 mm, length 1000 mm
Conveyor 3: belt width 20 mm, length 500 mm
Belt speed up to 30 m/min
FeedingSS 304 vibratory bowl feeder with stand and chute
UtilitiesElectric: 240 V AC, 1 phase, 5 A
Compressed air: 6–10 bar, oil-free clean air, 6 mm push-in connection
Ethernet connection for remote support
Operating conditions+10 °C to +40 °C; 40–90% RH non-condensing; max. altitude 1900 m

Source: Optomech FOSIS brochure. Specifications may change with product development; final figures are confirmed in your quotation. The full brochure with layout drawings is available through the brochure download form on this page.

Download the FOSIS Brochure

Get detailed specifications, technical data, and application information

How FOSIS Works

1

Automatic Feeding

Vibratory SS304 bowl feeder automatically orients and conveys seals to the inspection line

2

Multi-Camera Imaging

Advanced vision system captures high-resolution images of all three zones simultaneously

3

AI Defect Detection

Deep learning algorithms analyze images and identify 18+ defect types in milliseconds

4

Sort + Report + Trace

Defective items ejected pneumatically; data logged with images for complete traceability

FOSIS in Action

Regulatory Compliance

21 CFR Part 11

FDA compliant electronic records and signatures for pharmaceutical manufacturing

3-Level Access Control

Operator, Supervisor, and Administrator roles with secure login and audit trails

Schedule M & WHO-GMP

Meets international GMP standards for pharmaceutical manufacturing quality

Complete Traceability

Last 100 defects stored with images; full data export for batch validation

Technology Platform

Machine Vision

High-resolution multi-camera system capturing all seal zones with precision optics

AI Deep Learning

Neural networks trained on thousands of defect examples for accurate detection

Application-Specific Lighting

Optimized LED lighting to highlight defects across all three inspection zones

21" Touchscreen Display

Intuitive operator interface showing live inspection, statistics, and defect images

Pneumatic Ejection

High-speed pneumatic system for instant rejection of defective seals

Remote Access & Updates

Secure cloud connectivity for software updates and remote diagnostics

Industries We Serve

Injectable Pharmaceuticals

Flip-Off Seal Manufacturers

Oral Solid Dosage

FMCG Pharma Packaging

Why Choose Optomech

Industry Expertise

20+ years of pharmaceutical machine vision experience and proven track record

FDA Compliant

21 CFR Part 11 certified systems with comprehensive validation documentation

Global Support

24/7 technical support, spare parts availability, and on-site service worldwide

AI-Powered Accuracy

Deep learning algorithms continuously improve defect detection accuracy

Customizable Solutions

Flexible configurations for different seal sizes and defect requirements

ROI-Focused

Fast payback period with reduced waste, improved yield, and faster cycle times

Trusted by Leading Manufacturers

Hetero
Strides Shasun
GelCaps
Pravesha
Gopaldas Visram
Shally Engineering Plastics
SSF Plastics
Creative
ALPLA

Frequently Asked Questions

What is FOSIS? +
FOSIS (Flip-Off Seal Inspection System) is a high-speed pharmaceutical machine vision system that automatically inspects flip-off seals at speeds up to 600 caps per minute. It detects 18+ different types of defects across three inspection zones and is fully FDA 21 CFR Part 11 compliant.
What defects does FOSIS detect? +
FOSIS detects 18+ defect types including: cuts, wrinkles, strain marks, deformations, missing shells, black marks, dents, dirt, improper crimping, flash marks, short fill, black spots, colour variations, and missing plastic caps. Defects are identified across the outer aluminium shell, inner surface, and PP button zones.
Is FOSIS FDA compliant? +
Yes, FOSIS is fully compliant with FDA 21 CFR Part 11 for pharmaceutical manufacturing. It also meets WHO-GMP and Schedule M compliance requirements. The system provides complete electronic records with audit trails, 3-level access control, and comprehensive data traceability.
What seal sizes can FOSIS handle? +
FOSIS handles 5 different flip-off seal sizes: 13mm (Dia 15×H8mm), 20mm (Dia 22×H8mm), 28mm (Dia 31×11mm), 32mm (Dia 36×16mm), and 34mm (Dia 36×14mm). Quick-change configurations allow for rapid size adjustments between production runs.
What is the inspection speed? +
FOSIS can inspect up to 600 caps/minute for 13mm seals. Speed adjusts based on seal size, complexity of defects being detected, and production requirements. The system maintains consistent quality regardless of speed.
Does FOSIS provide traceability? +
Yes, FOSIS provides complete traceability. The system stores the last 100 defects with high-resolution images on the 21" touchscreen interface. All inspection data can be exported for batch validation, regulatory audits, and process improvement analysis.
What feeding system does FOSIS use? +
FOSIS uses a vibratory bowl feeder made from stainless steel SS304 (food/pharma grade). The feeder automatically orients seals correctly and conveys them to the inspection line at the required speed, eliminating manual handling.
How does FOSIS reject defective seals? +
FOSIS uses high-speed pneumatic ejection to instantly remove defective seals from the production line. The system is programmable for different rejection sensitivity levels and can be configured for different seal types and production requirements.
Can FOSIS integrate with existing production lines? +
Yes, FOSIS is designed for seamless integration into existing pharmaceutical production lines. It can connect to upstream filling machines and downstream packaging equipment with standard interfaces and data protocols. Our installation team handles all integration requirements.
What is the typical return on investment? +
Payback depends on your line. The returns typically come from reduction in waste, improved product yield, faster cycle times, and elimination of manual inspection costs. Additional benefits include reduced regulatory risk and improved customer satisfaction through consistent quality. Use our ROI calculator to estimate payback with your own numbers.

Pharma packaging compliance hub (FOSIS · Schedule M · WHO-GMP · 21 CFR Part 11) →

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📞 +91-7075961133 | info@optomech.in

Price in India

FOSIS price

₹25–40 lakh

Starting-from price band for a base configuration · ex-works (Hyderabad) · GST extra. Your exact price depends on configuration — share your requirement for a configured quote.

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Where can I read the primary regulations and standards?

Last reviewed: by the Optomech Engineers technical team.