How long should inspectors examine each unit?
A: At least 5 seconds, rotating vials in front of both white and black backgrounds.
Ask the Expert: Liquid Inspection & Challenging Products
18/12/25
Why Visual Inspection Matters for Biopharmaceuticals
Ensuring the absence of visible particulate contamination in biopharmaceutical products is critical for regulatory compliance and patient safety. Particulates can originate externally - from packaging, hair, or fibres - or internally, including protein aggregates, silicone droplets, or inorganic precipitates.
Challenges with Opalescent, Coloured & Opaque Solutions
Products like opalescent liquids, coloured/opaque solutions, and lyophilisates present unique visual inspection hurdles:
- Dye or opacity can mask particles
- Light transmission in coloured glass is limited
- Freeze-dried powders (lyophilisates) pose detection difficulties
Apollo II High-Intensity Liquid Viewer: A Cutting-Edge Solution
Adelphi Manufacturing’s Apollo II High-Intensity Liquid Viewer delivers up to 10,000 Lux, exceeding pharmacopeia standards. This level ensures visibility through coloured glass and enhances clarity for particulate detection.
Key benefits:
- Efficient detection in amber or coloured containers
- Ideal for opaque, dyed, or freeze-dried products
- Helps meet EU and US pharmacopoeia visual inspection requirements
Integrating Manual Inspection with Automation
While automated systems detect most defects, pharmacopoeia compliance still requires manual inspections for samples from each batch. Manual visual checks using the Apollo range of Liquid Inspection Units ensure regulatory compliance and support final quality assurance.
FAQs for Your Visual Inspection Process
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What light level is necessary?
A: Use ≥ 3,750 Lux, with high‑intensity units offering 8,000–10,000 Lux for optimal clarity.
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Is manual inspection still required?
A: Yes. Even with automation, manual inspection of sampled units remains mandatory under pharmacopeia rules.
Summary: Best Practices for Visual Inspection
| Step | Recommendation |
| 1. Prep | Choose white & black backgrounds |
| 2. Lighting | Use ≥ 3,750 Lux (8,000–10,000 for tough cases) |
| 3. Technique | Rotate vial for at least 5 seconds |
| 4. Documentation | Record results and inspection settings |
| 5. Compliance | Follow pharmacopeia guidelines and use validated equipment |
Enhance Your Inspection Workflow
Equip your team with a visual inspection system like the Apollo II High-Intensity Unit to ensure compliance and safeguard product quality - even for difficult-to-inspect formulations. Need support with integration planning or staff training? Adelphi offers tailored guidance for seamless adoption.