I. Scope of Application for Ampoule Products

Ampoules are specifically designed for the packaging of sterile injectable medicines and are widely used in active pharmaceutical ingredient (API) manufacturers, pharmaceutical formulation companies and biopharmaceutical and vaccine manufacturers. Products ranging from routine clinical injections to bulk solutions for specialised vaccines are packaged in ampoules of the appropriate specifications. The Medicines and Healthcare products Regulatory Agency (MHRA) has mandatory acceptance criteria for the physical dimensions of ampoules, and products that do not meet these dimensional requirements are prohibited from being used in pharmaceutical filling operations.

II. Challenges in Inspecting Ampoule Dimensions and Specification Requirements

1. Inspection challenges: Ampoules are small and thin-walled, making them prone to deformation; they often feature curved necks and irregular shoulder structures. Standard calipers struggle to accurately measure the wall thickness of curved sections, and manual measurements lack repeatability;

2. Inspection criteria: National standards require the measurement of six key parameters: total height, outer diameter of the mouth, body diameter, base thickness, neck wall thickness and concentricity. Even minute dimensional deviations can lead to filling faults, burstage during sterilisation and potential drug safety hazards;

3. Production line requirements: Both pharmaceutical companies and packaging material manufacturers require in-line inspection to prevent defective products from entering the finished goods stream, whilst balancing inspection accuracy with production cycle times.

III. Core Advantages of the Telecentric Measurement System

Telecentric Measurement Systems are the preferred equipment for ampoule dimension inspection, offering three key advantages:

1. Measurement accuracy of up to 1.5 μm; non-contact optical imaging measurement ensures no scratches to thin-walled ampoules, whilst providing precise readings of wall thickness at irregularly shaped bottle necks and shoulders;

2. Fast measurement speed; continuous in-line inspection alongside the production line, with real-time sorting of good and defective products, adapting to the production rhythm of automated lines;

3. Simple operation with a visual user interface; specification parameters are pre-loaded into the system, eliminating the need for repeated debugging during product changeovers; inspection reports are generated automatically, facilitating quality traceability for enterprises and easily meeting GMP acceptance standards for pharmaceutical packaging materials.

IV. Graph of Test Results