Strip Oral Film Manufacturer for Custom Nutraceutical Products

The plant operates coating lines with a controlled drying tunnel, which lets us hold film thickness within a tight tolerance across a full batch. We cast water-soluble films from pullulan, HPMC or modified starch, depending on the active and the target dissolve time. Standard strip dimensions are 22 mm x 35 mm, but we can cut custom shapes for brand differentiation. Line capacity supports runs from pilot scale up to 500,000 units per month per SKU.

Every batch moves through in-process checks: film weight, moisture content, thickness, dissolution time and seal integrity. We can produce single-strip sachets or multi-count pouches, and we run both foil and paper-based laminates. For brands scaling from a pilot to retail, the same equipment and process parameters carry over, which keeps the second batch consistent with the first.

We formulate around the active, not the other way round. Common actives include melatonin, caffeine, vitamin B12, vitamin D3, CBD isolate, electrolytes and herbal extracts. Taste masking matters: films dissolve on the tongue, so we use cooling agents, sweeteners and flavour systems to cover bitter notes. Typical active loading is 1 mg to 50 mg per strip, and we can go higher for some water-soluble ingredients after a stability check.

The R&D team tests compatibility between the active and the film base before any pilot run. If an ingredient degrades in a water-based film, we can switch to a solvent-cast or a two-layer format. We also run accelerated stability at 40°C/75% RH for 3 months and real-time testing at 25°C/60% RH for 12-24 months. Shelf life is usually 18-24 months in a sealed sachet.

The facility is GMP-certified and registered with the FDA for dietary supplement manufacturing. We hold ISO 22000 and HACCP, and we can produce under halal or vegan programmes when the formula and supply chain support it. Every batch ships with a certificate of analysis covering identity, potency, microbial limits, heavy metals and dissolution time. We retain samples for 24 months.

For export, we handle documentation for the US, EU, UK and Middle East, including health certificates, free-sale certificates and ingredient statements. Packaging can be labelled for your market, or shipped in bulk for local filling. Standard shipping is by air or sea from Shenzhen or Hong Kong. We work with your freight forwarder or arrange delivery through ours.

Every strip oral film batch is tested against a written specification before release. Incoming raw materials are checked for identity by FTIR or HPLC and for potency where applicable. During production, the film casting solution is sampled for viscosity and active dispersion uniformity, and finished strips are tested for weight variation, thickness, moisture content and disintegration time. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella, with heavy metals (lead, cadmium, arsenic, mercury) screened by ICP-MS. Potency is confirmed by HPLC against a validated method, and results are recorded on the batch record.

A certificate of analysis (COA) is issued for each batch and includes the product name, batch number, manufacturing date, expiry date, active ingredient content, microbial results, heavy metals, disintegration time and a statement of conformity to specification. Retention samples of every batch are kept for the full shelf life plus six months, stored under controlled conditions. Stability testing follows an accelerated protocol at 40°C/75% RH for six months and real-time testing at 25°C/60% RH for up to 24 months, with time points at 0, 3, 6, 12, 18 and 24 months. This data supports the expiry date printed on the pouch.

Disintegration testing is performed on finished strips using a petri dish method with purified water at 37°C, and the mean disintegration time must fall within the agreed specification, typically under 60 seconds for thin films. For strips containing actives sensitive to moisture, water activity is measured and the drying profile is adjusted accordingly. Any out-of-specification result triggers a documented investigation, and affected batches are placed on hold until the root cause is identified and corrective action is verified. Batch records and test data are retained for five years and are available for customer review during audits.

Strip oral films are packed in single-serve sachets, 10 to 30 count pouches, tubes or cartons. Each sachet is sealed with a controlled heat profile to protect the film from moisture and oxygen, and the pouch material can include an aluminium barrier layer where the formula requires it. For retail, we offer child-resistant pouches, display cartons and shrink-wrapped trays. Labelling follows the US FDA dietary supplement requirements: statement of identity, net quantity, supplement facts panel, ingredient list, directions for use, and the manufacturer or distributor name and address. Allergen declarations and warning statements are included where applicable.

Lot and expiry coding are applied to each primary unit using inkjet or thermal transfer printing, with the format agreed before production. Cartons are specified with dimensions, board grade and print method, and pallet configurations are designed to maximise container fill while meeting retailer requirements. For Amazon sellers, we can apply FNSKU labels and poly-bag units with the appropriate suffocation warning. We do not provide legal review of label claims, but we check that the artwork supplied matches the approved formula and that mandatory elements are present before printing.

Before mass production, a packaging proof is issued for customer sign-off, covering dieline, colour and text. We can match Pantone colours and supply digital proofs or physical samples. Retail compliance checks include barcode verification (UPC or EAN) and confirmation that the supplement facts panel reflects the tested potency. Cartons are packed in corrugated shippers with a maximum weight of 15 kg per shipper, and pallets are stretch-wrapped and labelled with batch and quantity information. For markets requiring a responsible person address, we can print the customer's EU or UK address on the label.

The sampling process starts with a formulation brief and target film weight. We provide a quotation within three working days and, once accepted, produce samples in 7 to 10 working days. Sample quantities are typically 50 to 100 strips per flavour or active, supplied in plain pouches with a preliminary COA. If the sample requires adjustment, one round of reformulation is included at no extra cost, with a further 5 to 7 working days. Sampling fees are credited against the first mass production order.

Mass production begins after written approval of the sample, artwork and packaging proof. The production window is 20 to 35 working days depending on film weight, active complexity and packaging format. For orders above 50,000 units, we recommend booking capacity four to six weeks in advance. We provide a production schedule with milestone dates and share in-process photographs at the casting stage. Delays caused by artwork changes or missing label elements are communicated within 24 hours, and the revised schedule is confirmed in writing.

Shipping is arranged by air or sea. Air freight takes 5 to 10 days door to door and is suitable for orders under 500 kg or for time-sensitive launches. Sea freight takes 25 to 40 days port to port depending on destination, and is more economical for full pallets. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for selected destinations. Documents provided include COA, MSDS, free-sale certificate, and phytosanitary certificate where relevant. We do not provide customs brokerage, but we work with the customer's forwarder and supply the commercial invoice and packing list.