Two-in-One Capsule Manufacturer for Dual-Release Formulas

A two-in-one capsule is not a blend. It is a containment system. In tablet-in-capsule, a compressed mini-tablet sits inside a shell alongside powder or pellets. In pellet-in-capsule, two pellet populations with different coatings share one shell. Dual-chamber shells keep a liquid and a powder apart until swallowing. Each format needs its own filling sequence and weight checks.

EUPHM runs three filling lines for these builds. Line capacity is 60,000 to 120,000 capsules per shift, depending on format. Tablet cores are compressed on a separate rotary press, then fed into the capsule filler. We verify tablet weight, capsule fill weight and seal integrity every 30 minutes. That cadence catches drift before a batch is finished.

Not every pair of ingredients belongs in one shell. Moisture-sensitive probiotics and hygroscopic salts will pull water from each other. Oils can soften gelatin. Acidic actives can degrade a coating before the capsule is even bottled. The practical fix is separation: coat one active, dry the other, or use a dual-chamber shell. We test compatibility on a 500-capsule bench run before quoting a full batch.

Two-in-one formats also change your label. If the two actives have different release claims, you need a dissolution method that proves both. We develop and validate that method in-house. Typical fill weights run from 200 mg to 1,200 mg total, with tablet cores from 50 mg to 400 mg. Larger cores force a bigger shell, which affects bottle count and shipping cost.

Every two-in-one batch gets identity testing on incoming actives, a fill-weight check at start, middle and end of run, and a disintegration or dissolution test on the finished capsules. The facility is GMP-certified, ISO 22000 and HACCP. If your market needs halal or vegan status, we schedule that documentation before production, not after.

For export, we ship FOB Shenzhen or Hong Kong. Standard lead time is 20-35 working days after you approve the sample and artwork. Air freight samples take 3-5 days; sea freight to the US or EU runs 25-40 days. We provide a certificate of analysis, a certificate of origin and a full ingredient traceability file with each shipment.

Every two-in-one capsule batch is tested against a written specification before release. Incoming raw materials are sampled for identity by FTIR or HPLC, and each active is assayed for potency. Excipients and capsule shells are checked for microbial limits and, where relevant, for residual solvents. During encapsulation, in-process checks cover fill weight at the start, middle and end of each shift, with a target tolerance of plus or minus 5 per cent. Sealing integrity is checked by visual inspection and leak testing on a defined sample size.

Finished capsules are tested for potency, microbial contamination (total aerobic count, yeast and mould, E. coli and Salmonella), heavy metals (lead, cadmium, arsenic, mercury) and disintegration time. For dual-release claims, dissolution testing is run at agreed time points, typically 30, 60 and 120 minutes, using USP apparatus 1 or 2. A certificate of analysis (COA) is issued per batch and includes the batch number, manufacture and expiry dates, test methods, specification limits and actual results. Retained samples of each batch are stored for at least two years beyond expiry under controlled conditions.

Stability follows a standard protocol: 25 degrees Celsius and 60 per cent relative humidity for long-term, with accelerated conditions at 40 degrees Celsius and 75 per cent relative humidity for six months. Where a customer requires a specific shelf life, real-time data is generated on the first three production batches. Documentation packs include batch records, deviation reports if any, and cleaning records for the filling line. These are provided in English as standard and can be translated on request.

Two-in-one capsules can be packed in HDPE bottles (typically 30, 60, 90 or 120 counts), blister packs, stick packs or sachets. Bottles are induction-sealed and fitted with child-resistant or standard closures depending on market requirements. Blisters use PVC/PVDC or alu-alu material for moisture protection. Cartons are printed to customer artwork and include lot number and expiry date in the required format. Pallet specifications are agreed at order stage: standard 1200 x 1000 mm pallets, stretch-wrapped and corner-protected, with a maximum height of 1.8 metres for sea freight.

For the US market, labels must carry the supplement facts panel, ingredient list in descending order of weight, allergen statements, and the manufacturer or distributor address. EU labels require nutrition declaration, allergens and a best-before date. Lot and expiry coding is applied by inkjet or laser on the bottle, blister or carton, and must remain legible for the declared shelf life. We can apply Amazon FNSKU labels and poly-bag units for FBA shipments, and we check retail compliance points such as barcode scannability and font size against the artwork you supply.

Artwork proofing is done before printing. We provide a dieline and a PDF proof for sign-off, and we keep approved artwork on file for repeat orders. If you supply your own packaging components, we can run them on our lines after a line trial. Packaging lead times are typically 10 to 15 working days for printed cartons and labels, and this runs in parallel with production.

Sampling starts with a formulation brief and a target dose. We provide a quotation within two working days and, once confirmed, a sample of 50 to 100 capsules in 7 to 10 working days. Sample costs are credited against the first mass-production order. Mass production runs 20 to 35 working days after sample approval and receipt of packaging materials. MOQ is 1,000 units per SKU for retail bottling, with lower thresholds for pilot runs subject to a line-clearance fee.

Shipping is arranged by air or sea. Air freight takes 5 to 10 days door to door and suits pilot or urgent orders. Sea freight takes 25 to 40 days depending on destination port. We work on EXW, FOB Shenzhen or Hong Kong, and DDP terms for selected markets. DDP includes customs clearance and duty, and is quoted per shipment. For sea freight, we provide a packing list, commercial invoice and bill of lading. For air freight, an air waybill is issued.

Documents provided with each shipment include the COA, material safety data sheet (MSDS) where applicable, free-sale certificate, and phytosanitary certificate for plant-derived ingredients where the destination requires it. Certificates of origin can be issued on request. We recommend booking sea freight at least four weeks before the required delivery date to allow for port congestion. All lead times are counted from the working day after approval and deposit receipt.