How Softgels Are Made: A Sourcing Guide for Brands

On a rotary die line, gelatin or a vegan gelling agent is melted, de-aerated and spread onto two chilled casting drums to form ribbons roughly 0.6–0.9 mm thick. The ribbons pass over a rotating die roll with capsule-shaped pockets. As the dies meet, a fill pump injects a metered dose between the two ribbons, and the die edges weld the shell closed. The whole cycle runs continuously, so output is measured in capsules per hour rather than per batch.

Capacity depends on capsule size and fill viscosity. Smaller softgels run faster; large 1,200–1,500 mg fish oil softgels run slower because the fill pump needs more time per dose. Standard lines handle oblong, round and oval shapes, with fill weights from about 150 mg to 1,500 mg. Tolerances on fill weight are typically held within ±3–5%, which matters for label claims on actives such as vitamin D or CoQ10. After drying, softgels pass through a tumbler to remove residual surface oil before inspection and packing.

The fill decides most of the formulation work. Oil-based fills — fish oil, MCT, vitamin E, CBD — disperse easily and need little more than an antioxidant such as mixed tocopherols. Suspension fills, where a powder is dispersed in oil, require milling to a tight particle size so the powder does not settle or block the fill pump. Emulsified and self-emulsifying systems are used when an active needs better dispersion in the gut, but they add cost and require stability testing.

Shell composition must match the fill. High-water-activity fills can soften gelatin, so a plasticiser adjustment or a starch-based vegan shell is used instead. Enteric softgels use a shell that resists stomach acid and releases in the small intestine; these are harder to seal and usually carry a higher MOQ. For halal claims, the gelatin source and the entire line must be segregated. Vegan shells based on modified starch or carrageenan behave differently on the die, so trial runs are normal before scale-up.

In-process checks run throughout the shift: fill weight, shell thickness, seam integrity and capsule dimensions are sampled at set intervals. After drying, softgels are inspected for leaks, deformation and fill migration. A leakage test and a disintegration test confirm the shell performs as intended. For actives with a label claim, assays are run on the finished fill to confirm potency within specification.

Documentation is what most buyers actually need. A GMP-certified, ISO 22000 and HACCP facility issues a certificate of analysis per batch, covering appearance, fill weight, assay, microbial limits and heavy metals. Certificates for halal or vegan status are held at ingredient and finished-product level, depending on the claim. Retain samples are kept for the shelf life of the product. Stability data — typically 24–36 months at 25°C/60% RH, with accelerated conditions — supports the expiry date printed on the label. FDA-registered facility status is relevant for US-bound shipments, but that is registration, not approval.

Every softgel batch is tested at three points: incoming raw materials, in-process fill and shell checks, and finished goods. For the fill, identity and potency are confirmed by HPLC or GC against a reference standard, with microbials (total aerobic count, yeast and mould, E. coli, Salmonella) tested to USP <2021> or equivalent. Heavy metals (lead, arsenic, cadmium, mercury) are screened by ICP-MS to USP <232> limits. Shell and finished capsules are checked for disintegration (USP <701>, typically under 30 minutes for gelatin) and for fill weight uniformity within ±5% of target.

A certificate of analysis (COA) is issued per batch and includes the product name, lot number, manufacture and expiry dates, tests performed with specifications and results, and a statement of conformity. Retention samples of every batch are held for at least two years beyond expiry under controlled conditions (typically 25°C/60% RH or 30°C/65% RH). Stability protocols follow ICH Q1A(R2): accelerated at 40°C/75% RH for six months and long-term at 25°C/60% RH for up to 36 months, with time points at 0, 3, 6, 9, 12, 18, 24 and 36 months as applicable.

Documentation packages are compiled per shipment and include the COA, master batch record extract, deviation reports if any, and a declaration of allergen status. For markets requiring it, a free-sale certificate and GMP certificate are provided. Batch records are retained for five years. If a specification is out of trend, the batch is placed on hold and an investigation is opened before release; the customer is notified in writing with the disposition.

Softgels are typically packed in HDPE bottles (60, 90, 120, 180 or 240 count) with induction seals and child-resistant or standard caps, or in blister packs (PVC/PVDC or alu-alu) for unit-dose or pharmacy channels. Stick packs and sachets are available for single-serve formats, though softgels are less common in sachets than powders. Bottle dimensions and label panel sizes are confirmed at artwork stage. Cartons are specified with lot number and expiry date inkjet-coded on the base and side panel, in a format agreed with the brand (for example LOT 12345, EXP 2027-08).

For US retail, the label must carry the statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value where applicable, ingredient list, and the address of the manufacturer or distributor. The FDA does not pre-approve labels, but structure/function claims must include the disclaimer. For Amazon, FNSKU labels are applied over the barcode or printed on the carton, and poly-bagging with a suffocation warning is required for loose bottles. We can print and apply FNSKU labels in-house.

Carton specifications are agreed per SKU: typically 12, 24 or 48 bottles per shipper, with gross weight and dimensions stated on the packing list. Pallets are built to 1,200 x 1,000 mm or 1,200 x 800 mm, stretch-wrapped and corner-boarded, with a maximum height of 1.8 m for sea freight or 1.6 m for air. Pallet labels include SSCC, batch and quantity. Retail compliance checks cover barcode scannability (GS1), nutrition rounding rules, and country-specific requirements such as the UK's novel food status or the EU's health claims register.

Sampling starts with a brief and formulation review. Prototype samples are typically ready in 7–10 working days; if a new shell colour or custom shape die is required, add 10–15 working days for tooling. Sample approval is confirmed in writing against a signed specification. Mass production then runs 20–35 working days after approval and receipt of deposit, depending on fill complexity, shell type and packaging format. Pilot runs below standard MOQ are possible at a higher unit cost, with MOQ set at 1,000 units per SKU for retail bottling.

Shipping is by air or sea. Air freight from Guangdong to the US or EU typically takes 5–8 days door-to-door; sea freight to the US West Coast is 18–25 days port-to-port, and to Europe 28–35 days. Incoterms offered are EXW, FOB (Shenzhen or Hong Kong), and DDP for selected destinations. DDP includes duties and customs clearance but requires an accurate HS code and product description; we confirm these at order stage. For DDP, the buyer remains the importer of record for regulatory purposes.

Documents provided per shipment include commercial invoice, packing list, bill of lading or air waybill, COA per batch, MSDS where applicable, free-sale certificate, and GMP certificate. Phytosanitary certificates are not normally required for softgels but can be arranged for gelatin of animal origin if the destination requires it. Certificate of origin (Form A, Form E or general CO) is available on request. We recommend booking sea freight at least three weeks before the requested ship date to secure space.