Pullulan Capsule Manufacturer for Vegan Supplement Brands

EUPHM runs automatic capsule filling lines for pullulan shells at speeds up to 60,000 capsules per hour, depending on fill weight and powder flow. We fill powders, granules, pellets and small tablets into pullulan capsules. Size 0 and size 1 are the most common for retail bottles; size 2 and 3 suit low-dose actives or children's formats. Fill weights typically range from 150 mg to 800 mg.

The plant handles bottle sizes from 30 cc to 500 cc, with induction sealing, child-resistant caps and desiccant options. We also run blister and sachet formats for sample and travel packs. Minimum order quantity is 1,000 units per SKU for retail bottling. Lower MOQs are available for pilot runs, typically 1,000-2,000 units, so brands can test a pullulan SKU before scaling.

Pullulan shells have low moisture content and low oxygen permeability, which helps protect oxidation-sensitive ingredients such as probiotics, omega-3 powders and vitamin C. They are also free from gelatin, starch and carrageenan, supporting vegan, halal claims. EUPHM's formulation team reviews each active for hygroscopicity, pH and flow, then recommends excipients that keep the fill weight consistent.

Common excipients include microcrystalline cellulose, magnesium stearate, silicon dioxide and rice hull powder. We can produce pullulan capsules with no titanium dioxide, using clean-label opacifiers where needed. If a formula contains oils or semi-solids, we assess whether a pullulan capsule or a liquid-filled alternative is more suitable. Stability testing follows ICH conditions, with 3-month accelerated data available before commercial production.

EUPHM operates an FDA-registered facility and holds GMP, ISO 22000 and HACCP certifications. Pullulan raw material is tested for identity, viscosity and microbial limits against a specification before release to production. Each batch has a certificate of analysis covering assay, fill weight, disintegration and microbial counts. Halal, vegan and certificates are available when the ingredient and shell supply chain supports the claim.

For export, we ship FOB Shenzhen or Hong Kong, with air freight for samples and sea freight for palletised orders. Typical documentation includes commercial invoice, packing list, certificate of origin, COA and, where required, health certificates. Lead time for mass production is 20-35 working days after PO and artwork approval. We can hold safety stock for repeat SKUs with a 6-month forecast.

Every pullulan capsule batch is sampled at three points: incoming raw material (pullulan powder and any active ingredients), in-process capsule shells and filled capsules, and finished packaged goods. Identity testing uses FTIR or HPLC against a reference standard. Potency assays are run for actives with established methods, with results reported as a percentage of label claim. Microbial testing covers total aerobic count, yeast and mould, E. coli, Salmonella and Staphylococcus aureus, with limits set to the target market's pharmacopoeial or food-supplement standards.

Heavy metals (lead, arsenic, cadmium, mercury) are tested by ICP-MS on each finished batch, with results compared to the applicable limit for the destination market. Disintegration testing follows USP <701> or the relevant food-standard method, with pullulan capsules typically disintegrating within 10 to 15 minutes in water at 37°C. For hygroscopic fills, we also check moisture content and capsule shell integrity after accelerated storage. All test data is recorded in the batch record and summarised in the certificate of analysis (COA).

The COA issued with each batch includes product name, batch number, manufacturing date, expiry date, capsule size, fill weight, and test results for appearance, identification, assay, microbials, heavy metals and disintegration. Where a customer supplies a specification, the COA reports against that specification and flags any out-of-specification result before release. Retention samples of every batch are kept for the shelf life plus 12 months, stored under labelled conditions. Stability protocols follow ICH Q1A(R2) where the customer requires it, with 0, 3, 6, 12, 18 and 24-month pull points at 25°C/60% RH and 30°C/65% RH, and accelerated conditions at 40°C/75% RH for six months.

Pullulan capsules can be packed in HDPE bottles (typically 60, 90, 120, 180 or 240 count), blister packs, stick packs or sachets. Bottles are induction-sealed and fitted with child-resistant or standard caps depending on market requirements. Blister forming uses PVC/PVDC or aluminium-aluminium for moisture-sensitive fills. Stick packs and sachets suit single-serve positioning and are filled on vertical form-fill-seal lines with nitrogen flushing where required. Carton specs are agreed per SKU: typical dimensions are 40 x 25 x 15 cm for a 60-count bottle carton, with pallet configurations of 48 to 60 cartons per layer and 4 to 6 layers per pallet, stretch-wrapped and corner-boarded for export.

For US-bound dietary supplements, the label must carry the statement of identity, net quantity of contents, supplement facts panel, ingredient list, allergen declaration where applicable, and the manufacturer or distributor name and address. We also print lot number and expiry date in a clear, legible format, with the format agreed in the artwork approval stage. For Amazon FNSKU compliance, we apply the FNSKU label over the existing barcode or print it directly on the carton, and can add poly-bagging and suffocation warnings where the marketplace requires them. Retail-ready cartons can be printed with GS1-128 barcodes and shipped floor-ready.

Artwork approval is a formal step: we provide a dieline and label proof, and production does not start until written approval is received. Label text is checked against the target market's regulatory requirements, but final legal responsibility for claims and label content rests with the brand owner. We can supply a free-sale certificate where the destination country requires one, and we keep a record of the approved artwork and label version with each batch record so that any retail compliance query can be traced back to the exact printed version.

Samples for pullulan capsule projects are typically ready in 7 to 10 working days after formula and specification confirmation. Sample quantities are usually 100 to 300 capsules per SKU, packed in labelled sample bottles. If a new capsule size or custom fill weight is required, add 3 to 5 working days for tooling and fill trials. Sample courier costs are borne by the customer and can be credited against the first production order at our discretion.

Mass production runs 20 to 35 working days after purchase order and artwork approval, depending on capsule size, fill complexity, packaging format and whether stability testing is required before release. Larger orders above 50,000 units per SKU may extend the window by 5 to 10 working days. We provide a production schedule at order confirmation and update it weekly. Air freight typically takes 3 to 7 days door to door, while sea freight to Europe or North America takes 25 to 40 days depending on port and routing. We ship under EXW, FOB Shenzhen or Hong Kong, or DDP for customers who prefer a landed-cost arrangement.

Documents provided with each shipment include the certificate of analysis, material safety data sheet where applicable, free-sale certificate, and phytosanitary certificate for plant-derived ingredients where the destination country requires it. Commercial invoice, packing list and bill of lading or airway bill are issued in the shipper's name as agreed. For DDP shipments, we handle import clearance and duty payment through our forwarder network, and provide the customs entry summary after delivery. All documents are sent electronically before dispatch so the customer can review them in advance.