Dissolvable Oral Film Manufacturer for Supplement Brands

Our Guangdong plant runs two casting lines with a combined daily output of 120,000 films. We use a water-based film solution and a precision coating head that controls thickness to ±5 microns. Drying tunnels maintain 45-55°C to protect heat-sensitive actives. Films are cut to 22 x 35 mm or 30 x 40 mm standard sizes, with custom shapes available. Inline vision systems check for holes, streaks, and edge tears at 200 films per minute.

Packaging lines handle single-dose sachets, multi-film pouches, and 30-count dispenser boxes. We can apply child-resistant closures, desiccant sachets, and tamper-evident seals. Changeover between SKUs takes 2-4 hours, which keeps small batch runs practical. For pilot runs under 1,000 units, we use a semi-automatic line with a 500-unit minimum. Full batch records and line clearance logs are kept for each run.

We formulate films with water-soluble actives up to 30% of the dry film weight. Common ingredients include vitamin B12, vitamin D3, melatonin, caffeine, CBD isolate, elderberry extract, and zinc. Taste masking uses sucralose, stevia, or monk fruit, with citric acid or malic acid for tartness. Film formers are pullulan, hydroxypropyl methylcellulose (HPMC), or modified starch. Each base has a different mouthfeel and dissolution time.

Dissolution time ranges from 15 to 45 seconds depending on thickness and polymer blend. We run accelerated stability studies at 40°C/75% RH for 6 months and real-time studies at 25°C/60% RH for 24 months. Actives that degrade with moisture, such as probiotics, need an oil-based film or a desiccant sachet. We test compatibility with your raw materials before quoting. Heavy metal and microbial testing follows USP <61> and <62> methods.

Every batch is tested for appearance, thickness, fill weight, dissolution time, and microbial limits. We retain samples for 24 months. Certificates of analysis include HPLC or ICP-MS results for actives and heavy metals. Our QA team reviews batch records before release. For US and EU clients, we provide documentation for FDA prior notice, EU food supplement notifications, and UK novel food checks where needed.

Shipping from Guangdong uses air freight for samples (3-5 days to US/EU) and sea freight for mass production (18-28 days to US West Coast, 22-30 days to EU ports). We handle halal certificates per batch. vegan claims require separate ingredient verification. MOQ for retail bottling is 1,000 units per SKU. Pilot runs can start at 500 units. Lead time for mass production is 20-35 working days after sample approval.

Every oral film batch is tested against a written specification before release. Incoming raw materials are sampled at 100% of containers for identity by FTIR or HPLC, and each lot is quarantined until the certificate of analysis from the supplier is verified. During casting, we check film thickness at the start, middle, and end of each roll using a calibrated micrometer, with a target of 50 to 120 microns and a tolerance of plus or minus 5%. Fill weight is verified by gravimetric analysis on 10 films per 1,000-unit run.

Finished films undergo potency testing by HPLC to confirm the active ingredient is within 90.0% to 110.0% of label claim, and uniformity of dosage units is assessed on 10 randomly selected films. Microbial testing includes total aerobic count, yeast and mould, and absence of E. coli and Salmonella, following USP <61> and <62> methods. Heavy metals are screened by ICP-MS for lead, arsenic, cadmium, and mercury against ICH Q3D limits. Disintegration time is measured in purified water at 37 degrees Celsius, with a target of under 60 seconds for most formulations.

A certificate of analysis is issued for each batch and includes the product name, lot number, manufacturing date, expiry date, active ingredient assay result, microbial results, heavy metals results, disintegration time, and a statement of conformity to specification. We retain samples of every batch for the full shelf life plus 12 months in a controlled stability chamber at 25 degrees Celsius and 60% relative humidity, and at 40 degrees Celsius and 75% relative humidity for accelerated studies. Stability protocols cover 0, 3, 6, 12, 18, and 24 months, with testing at each interval for potency, appearance, moisture content, and disintegration.

Batch records are reviewed by a qualified person before release, and any deviation is documented with a root cause analysis and corrective action. We provide a batch record summary on request for brand owners who need it for their own quality files. For oral film manufacturing, the critical control points are slurry homogeneity, casting thickness, drying temperature, and cutting accuracy, and each is logged with an in-process check at defined intervals.

Dissolvable oral films are typically packed in blister packs, stick packs, or sachets, and we can also fill into HDPE bottles with desiccant for multi-count formats. Blister options include PVC/PVDC and alu-alu for moisture-sensitive formulations, with cavity counts from 10 to 30 films per card. Stick packs are available in 30 to 100 mm widths, and sachets can be printed with up to 8 colours. Cartons are specified with 300 to 350 gsm board, and we can apply tamper-evident seals and child-resistant features where required.

For the US market, we set up FDA dietary supplement labels with the required elements: statement of identity, net quantity of contents, supplement facts panel, list of ingredients, and allergen declarations where applicable. We also include the manufacturer or distributor name and address, and lot code and expiry date in a legible format. For the EU and UK, we follow the relevant food supplement labelling rules, including the nutrition declaration and any authorised health claims. We do not print claims that are not substantiated by the brand owner.

Lot and expiry coding is applied by inkjet or laser on the primary pack and carton, with a format that matches the brand owner's traceability system. Cartons are packed in corrugated shippers with a maximum weight of 15 kg for manual handling, and pallets are configured to 1,200 by 1,000 mm or 1,200 by 800 mm with a maximum height of 1,800 mm including the pallet. We can print Amazon FNSKU labels and apply them to each unit, and we can also provide retail-ready packaging with a scannable GTIN on the carton.

Before mass production, we provide a dieline and a digital proof for approval, and we can supply a physical pre-production sample for retail compliance checks. For oral film manufacturing, packaging selection affects stability, so we recommend a moisture barrier appropriate to the formulation and a desiccant where the film is hygroscopic. We do not print certification logos unless the brand owner holds a valid certificate and provides written authorisation.

Sample development for a new oral film formulation takes 7 to 10 working days after we receive the brief and the active ingredient. This includes a formulation trial, film casting, and a small batch for sensory and stability checks. If the active ingredient requires a new analytical method, add 5 to 7 working days for method development and validation. We provide a sample report with assay, disintegration, and appearance results so the brand owner can confirm the specification before committing to a production order.

Mass production starts after sample approval and runs for 20 to 35 working days, depending on the film format, packaging, and whether the active ingredient is supplied by us or by the brand owner. The MOQ is 1,000 units per SKU for retail packaging, and lower for pilot runs. We schedule production in campaigns to reduce changeover losses, so a firm delivery date is confirmed only after the purchase order and artwork approval are received.

For delivery, we offer EXW, FOB, and DDP terms. Air freight from Guangdong to the US or EU typically takes 5 to 8 days door to door, while sea freight takes 25 to 35 days port to port. We provide a commercial invoice, packing list, certificate of analysis, material safety data sheet, and a free-sale certificate where required. For botanical ingredients, a phytosanitary certificate can be arranged if the destination country requires it. We do not arrange insurance unless requested in writing.

Shipping documents are issued within 3 working days of shipment, and we send scanned copies by email before the originals are couriered. For DDP shipments, we handle customs clearance and duties, and we provide a delivered cost breakdown before the order is confirmed. Brand owners should confirm the import requirements of the destination country, as some markets require additional registration or notification for dietary supplements.