Pharmaceutical and Regulated Production

Inspection, Handling and Traceability Systems with Defined Validation Requirements

Projects focus on controlled product presentation, measurable inspection, reject verification, data integrity and documented testing.

  • Vision inspection and OCR
  • Reject tracking and confirmation
  • Documentation and validation support
VI-300 Vision Inspection System

Regulated Applications

Inspection and Handling Functions That Require Clear Acceptance Criteria

Each proposal connects machine configuration, project checkpoints, maintainability and after-sales support to the buyer’s actual production conditions.

01

Code and Artwork Verification

OCR, OCV, barcode, batch and date-code checks.

02

Component and Closure Presence

Cap, seal, leaflet, insert and assembly verification.

03

Reject and Reconciliation

Tracked removal, confirmation, bin monitoring and count reconciliation.

04

Data and User Control

Result records, access levels, audit requirements and system interfaces.

Validation Risks

Make Inspection Logic, Reject Behavior and Data Requirements Explicit

Buyer Concern Engineering Response

The inspection request does not define actual defects or tolerances.

Create a defect catalogue with good, failed and normal-variation samples.

A failed product may not reach the reject container.

Track each result to the reject point and verify successful removal.

Data expectations are added after the hardware is selected.

Define records, images, user access, retention and interfaces during concept design.

Validation Approach

Challenge the Inspection with Known Good, Known Defect and Normal Variation

Acceptance includes false-reject review, missed-defect challenges, reject confirmation and data checks.

  1. 01

    Approved Samples and Test Basis

    Confirm products, formats, packaging materials, speeds and acceptance methods before FAT.

  2. 02

    Mechanical and Electrical Inspection

    Review build quality, components, guarding, access, wiring, labels and utilities.

  3. 03

    Function and Performance Run

    Test automatic modes, recipes, output, quality, rejects and accumulation behavior.

  4. 04

    Fault, Safety and Recovery

    Challenge alarms, interlocks, emergency stops, blocked products and controlled restart.

  5. 05

    Documents and Punch-List Closure

    Review manuals, drawings, backups, spare parts, training and remaining actions.

VI-300 Vision Inspection SystemCL-200 Compact Packaging Line

Inspection Engineering

Optics, Product Handling and Software Must Be Designed as One System

Camera resolution alone does not guarantee inspection quality. Lighting, working distance, motion, product orientation and defect contrast are validated together.

  • Defect and sample study

    Define the smallest required defect and normal process variation.

  • Imaging and handling design

    Select camera, lens, lighting, enclosure and product presentation.

  • Validation and data plan

    Agree challenge samples, reject behavior, records and user controls.

Validation Documents

Inspection Specifications, Test Protocols and Result Records

Replace demonstration files with approved quality and validation documents appropriate to the destination market.

System Overview

Automation Equipment Catalogue

A structured overview of machine platforms and integration services.

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Quality Document

Factory Acceptance Test Template

Example checkpoints for function, speed, safety and documentation review.

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Compliance

Electrical & Safety Documentation

Project documentation can be prepared around destination requirements.

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VI-300 Vision Inspection System

Inspection Project

Multi-Camera Label, Code and Closure Inspection with Verified Rejection

The project combined controlled product handling, several camera views, code verification and reject confirmation under one recipe and result-recording system.

  • Target output: 30 cases/min
  • Central line controls and production status
  • FAT completed with customer samples
  • Operator training and remote diagnostics

Regulated Production FAQ

Validation, Data, Reject and Change-Control Questions

Actual compliance obligations must be confirmed by the buyer and project quality team.

What information is needed for an automation quotation?

Please share product dimensions and weight, current packaging, target speed, required pack pattern, available layout, utilities, destination standard and any upstream or downstream equipment.

Can one machine handle multiple product sizes?

Usually yes, within a defined operating range. The proposal should identify no-tool adjustments, change parts, recipe settings and the expected changeover time.

How is the system tested before shipment?

A factory acceptance test is prepared around the agreed products, speed, functions, alarms, safety checks and documentation. Customer samples are strongly recommended.

Do you support installation and operator training?

Remote guidance and on-site commissioning can be planned according to project scope, location and local contractor capability.

Which PLC and electrical brands are available?

Siemens, Allen-Bradley and other internationally supported platforms can be discussed. Final selection depends on destination standards and the customer’s maintenance preference.

Define the Inspection Requirement

Share the Defect Catalogue, Samples and Data Expectations

The first feasibility review should identify inspection limits, sample gaps and validation assumptions.

  • Application review before quotation
  • Layout and interface planning
  • FAT, installation and support options