Automated pharmaceutical vial inspection system

01

Plan how the machine will be qualified

FDA's December 2021 draft guidance on visible particulates in injectable products — nonbinding and issued for comment — says each final container must be inspected using a qualified method and all units found to contain visible particulates must be rejected, and that trained personnel, automated technology or both should be used for this 100% inspection, followed by AQL sampling by the quality unit. [1]

It says automated inspection machines should be validated to meet or surpass human inspection capabilities and can be qualified using training standards or artificial intelligence technology. Test sets should mix good units and defective units with visible particulates, include examples from the lower limit of visual detection found in threshold studies, and keep defective units to no more than 10–20 percent of the set. [1]

The guidance notes that visual detection is probabilistic and depends on the product and the size and shape of the particle, that automated technology may detect particles at the lower end of the visual range with greater statistical reliability than manual inspection, and that manufacturers may need to adjust in-process alert and action limits when they change from manual to automated inspection. For opaque products and containers such as lyophilized powders, suspensions and tinted vials, it points to technologies such as X-ray and to supplemental destructive testing. [1]

Editorial calculation: a 300-unit qualification set at the 10–20% ceiling would hold no more than 30–60 defective units. Agree the set size, defect types and acceptance criteria with your quality unit before the factory acceptance test.

Give the supplier your products (liquid, lyophilized, suspension; tinted or clear), container types and dimensions, required throughput, defect list with priorities, defect library and test-set plan, required reject and false-reject targets, leak-test needs, data and audit-trail requirements, line integration and site utilities.

02

Set throughput, camera stations and container range

Körber's specification table for its basic automated platforms for vials, ampoules and cartridges lists throughput of up to 600 containers per minute for the VI, MS and CS series, container diameters up to 52 mm, and up to 13, 9 and 6 camera stations respectively (8, 6 and 4 inside the carousel), with up to 10, 10 and 5 outfeed channels and footprints of 1,500 × 1,800, 1,400 × 1,500 and 1,475 × 1,350 mm. [2]

The table lists HVLD leak-test integration for all three and headspace analysis (HSA) integration into the carousel as an option, with Bubble-X and 3D inspection integrable on VI and MS only. [2] Körber's overview adds outputs of up to 1,000 per minute for nested formats, deep-learning tools for particle and cosmetic inspection, and leak testing by high-voltage leak detection or headspace analysis for liquid and lyophilized products. [3]

Editorial calculation: at 600 containers per minute a machine inspects up to 36,000 units an hour, so a 100,000-unit batch needs at least about 2.8 hours of running time before changeovers, re-inspection or stoppages. The inspection rate itself should be qualified, as FDA's draft guidance says for all techniques. [2] [1]

A linked supplier describes rotary machines that spin the container at high speed, brake it and image it, using reflected, diffraction and transmitted light for different particle types, with ejection by a dial wheel and compressed air; it lists rotary models at 400 and 600 bpm. [4]

03

Rotary inspection machines at 400 and 600 bpm with HVLD in the linked listing

The listing reviewed offers rotary visual inspection machines for vials, ampoules and lyophilized products together with HVLD units; ask for the validation package, the particle detection data on your own defect set and the false-reject rate on good units.

04

Spin-and-brake handling, camera stations, algorithms, outfeeds and leak test in a vial inspection machine

05

Speed, particle size, container range, reject rates and interfaces for a vial inspection quotation

Published values in this table come from FDA's draft guidance, Körber's platform tables and MIC Machinery's listing; where none states a value, the row says what to obtain from the supplier.

06

Send the products, defects and validation plan together

Paste it into your enquiry below or into an email to a maker, then replace every bracket.

Products: [liquid; lyophilized; suspension; colour]
Containers: [vial; ampoule; cartridge; sizes]
Throughput: [units/min; batch size]
Defects: [particle types; cosmetic; fill; closure]
Validation: [defect library; test sets; acceptance]
Leak test: [HVLD; headspace; none]
Integration: [infeed; outfeed; data; audit trail]
Site: [utilities; room class; space]

See manufacturer records Send an enquiry through CNFX