Map oxidation exposure across the line
Begin with the incoming oil and follow it to the packaged softgel. Record container storage, opening, transfer method, tank design, hold time, process temperature, filling conditions, drying and final packaging. The objective is to find uncontrolled exposure points, not to assume every line has the same risk.
Review light and oxygen exposure alongside temperature and time. A process change that shortens open holding or improves closure may help, but the result should be checked with the plant’s own measurements and quality criteria.
Qualify the fill oil for the formula
Specify the oil identity, EPA/DHA profile, molecular form, antioxidant system where relevant, sensory criteria, and oxidation tests. Confirm whether the supplier’s COA is batch-specific and whether its methods match the agreed specification.
Run the candidate in the intended formula. Viscosity, fill mass, capsule dimensions, shell compatibility and line settings can influence the finished product. Concentration alone does not establish the right fill oil or capsule size.
Control transfer and holding
Use documented procedures for opening, sampling, transfer, tank closure and any inert-gas protection specified for the process. Track the time between opening and use, container identity, tank lot and production batch. Keep the actual limits and operating instructions in the facility’s validated procedure rather than relying on generic online values.
If oil is returned to storage or a partially used container is retained, follow the site’s approved handling and re-test policy. Record exceptions so the affected production lots can be assessed.
Verify packaging and finished-product criteria
Select bottle, blister, closure, headspace and secondary packaging according to the product’s use, market, distribution route and stability evidence. Do not infer shelf life from ingredient data alone. Define finished-product assay, oxidation, sensory and package-integrity checks within the product quality plan.
Softgel oxidation review checklist
- Incoming oil COA and specification are linked to the production lot.
- Opening, transfer, hold-time and temperature records are available.
- Tank and container closure practices are documented.
- Packaging and storage assumptions match the stability programme.
- Finished-product release and stability criteria are defined.
- Deviations trigger a documented quality review.
References
- GOED Best Practice Guidelines: Oxidation Control — industry guidance on sampling and handling oxidation-sensitive oils.
- GOED Voluntary Monograph — relevant analytical methods and limitations, including flavoured oils.