Prebiotics Capsule Manufacturer for Your Own Label

EUPHM runs encapsulation lines with a rated output of 120,000-200,000 capsules per shift, depending on fill weight and shell type. For prebiotics, we typically use HPMC shells for vegan and halal projects, and gelatin where cost per unit matters more. Size 0 and size 1 are the most common for 300-500 mg blends. We can run size 2 for lower-dose synbiotic concepts. Powder blends are blended in stainless steel ribbon or V-blenders with batch records, then encapsulated under controlled temperature and humidity. This matters because inulin and FOS absorb moisture quickly and can stick in the dosator if the room is not controlled.

For pilot runs, we can produce 1,000-2,000 units to support stability and label validation before a full retail batch. Pilot runs use the same equipment and batch documentation as mass production, so scale-up is a repeat of a known process rather than a new one. If you are comparing capsule formats, our capsule manufacturer page covers hard-shell, vegetarian and delayed-release options. Prebiotic blends are often paired with probiotic strains, digestive enzymes or botanical extracts. We keep those as separate blend steps to avoid moisture transfer between hygroscopic and sensitive ingredients.

Prebiotic ingredients vary widely in dose and flow. Inulin and oligofructose are usually dosed at 300-500 mg per capsule; GOS and XOS often sit at 200-400 mg; resistant dextrin can go higher but adds bulk. We adjust excipients to keep the blend free-flowing: typically 1-3% silicon dioxide or magnesium stearate, and in some cases microcrystalline cellulose. If you want a clean-label capsule, we can run without magnesium stearate, but expect slower line speeds and a higher fill-weight variance. We test angle of repose and bulk density on every incoming lot before it enters a formula.

Capsule shells also carry label claims. HPMC is suitable for vegan, halal positioning. Gelatin is not. For organic-certified projects, the prebiotic ingredient, capsule shell and any carrier must all be on the approved input list. We can source organic inulin and organic acacia fibre with documentation. Synbiotic concepts combine a prebiotic with a probiotic strain; in that case we recommend a separate probiotic blend step and a desiccant in the bottle. Common finished doses are 1-2 capsules per day, which usually means a 30, 60 or 90 count bottle.

Every prebiotic batch is tested for identity, moisture, microbial limits and fill weight. We retain samples for 24 months. Certificates of analysis are issued per batch and include the tests your market requires. For the EU and UK, we can test for heavy metals, pesticide residues and allergens. For the Middle East, halal certificates are available on request, depending on the capsule shell and ingredient sources. The facility is GMP-certified and holds ISO 22000 and HACCP. It is an FDA-registered facility for food and dietary supplement manufacturing, not an FDA-approved drug facility.

Lead times are 20-35 working days for mass production after you approve the sample and artwork. Bottling, labelling and cartoning run on the same site, so you avoid a second supplier for retail packaging. We ship FOB Shenzhen or Yantian, with air freight for pilot runs. Typical retail configurations are 30, 60, 90 and 120 count in HDPE or PET bottles with induction seals. If you need stick packs or sachets instead of capsules, we can quote those from the same prebiotic blend. Documentation packs include batch records, COA, MSDS, halal certificates and organic transaction certificates where applicable.

Every prebiotic capsule batch is sampled at three points: incoming raw material, in-process blend, and finished capsules. Identity testing by FTIR confirms inulin, FOS, GOS, XOS or resistant starch against reference spectra. Potency is assayed by HPLC or enzymatic methods depending on the prebiotic, with results expressed as percentage of label claim. Microbial testing covers total aerobic count, yeast and mould, E. coli, Salmonella and Staphylococcus aureus. Heavy metals (lead, arsenic, cadmium, mercury) are tested by ICP-MS against USP <232> limits. Disintegration testing follows USP <701> for the chosen capsule shell.

A certificate of analysis (COA) is issued per batch and includes the product name, batch number, manufacturing date, expiry date, tests performed, specification limits, results and pass/fail status. It also lists the capsule shell type and fill weight. Retention samples of each batch are kept for two years at 25°C/60% RH and 30°C/65% RH, with a third set at 40°C/75% RH for accelerated stability. Stability protocols run at 0, 3, 6, 12, 18 and 24 months, monitoring potency, microbials, moisture and disintegration.

Microbial limits for prebiotic capsules are set at total aerobic count ≤10,000 cfu/g, yeast and mould ≤100 cfu/g, and absence of pathogens in 10 g. Moisture content is controlled to ≤5% for hygroscopic prebiotics such as FOS and XOS, using sealed capsule shells and desiccant sachets in the finished bottle where needed. Water activity of the blend is checked before encapsulation to avoid shell softening. If you require custom specifications, such as tighter heavy metal limits or additional pesticide screening for plant-derived inulin, these are added to the batch record and COA.

Batch records are retained for five years and are available for audit by appointment. Deviations are documented with root cause and corrective action. For prebiotic blends containing multiple ingredients, each component is tested individually before blending, and the final blend is verified for uniformity by sampling from top, middle and bottom of the mixer. This ensures that low-dose prebiotics such as XOS are evenly distributed.

Prebiotic capsules can be packed in HDPE bottles (30, 60, 90, 120 or 180 count), blister packs (10, 14 or 21 capsules per card), stick packs (single-dose powder, if you switch format) or sachets. Bottles are induction-sealed and fitted with child-resistant or standard caps. Desiccant canisters or silica gel sachets are added for hygroscopic formulas. Labels can be supplied by you or printed by us; we hold FDA dietary supplement label templates and can review your artwork for the required elements: statement of identity, net quantity, supplement facts panel, other ingredients, directions, warnings, and manufacturer/distributor details.

Lot and expiry coding is applied by inkjet or laser on the bottle, carton and shipper. Expiry is set at 24 months from manufacture for standard prebiotic capsules, supported by stability data. Cartons are made from 300-350 gsm board, printed up to six colours, and can include a leaflet. Shipper cartons are 5-ply corrugated, with a maximum weight of 15 kg for manual handling. Palletisation follows standard 1200 x 1000 mm or 1200 x 800 mm pallets, with stretch wrap and edge protectors; we provide a packing list with carton dimensions, net and gross weights, and pallet count.

For Amazon FBA or retail compliance, we can apply FNSKU labels, poly-bag the bottles with a suffocation warning, and print the carton labels to your specification. We do not provide Amazon seller support, but we can prepare the shipment so it meets FBA requirements. Retail-ready packaging such as display cartons or shelf-ready trays can be quoted separately. All packaging materials are food-grade and meet EU 10/2011 and FDA 21 CFR 174-190 requirements for indirect food contact.

If you sell in the EU, we can include the required allergen statement and the name and address of the responsible person. For the US, we follow FDA 21 CFR 101.36 for supplement facts. We do not provide legal review of claims; you are responsible for ensuring that structure/function claims comply with the DSHEA and FTC rules. We can provide a template label for your regulatory team to complete.

The sample timeline starts with a brief: you provide the formula, capsule size, shell type and packaging. We confirm feasibility within two working days. If raw materials are in stock, samples are produced in 7-10 working days and shipped by courier at your cost. Sample quantities are typically 50-100 capsules per SKU, packed in labelled bottles. If custom raw materials are needed, add 5-7 days for sourcing. Sample fees are credited against the first production order above 5,000 units.

Mass production lead time is 20-35 working days after approval of the sample and receipt of the deposit. This includes raw material testing, blending, encapsulation, packaging and QC release. If you need printed cartons or custom bottles, add 10-15 days for packaging production. We provide a production schedule with milestones. For rush orders, we can compress to 15-20 working days subject to capacity and raw material availability, with a surcharge.

Shipping options include air freight (5-10 days to major hubs) and sea freight (25-40 days depending on destination). We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most countries. DDP includes customs clearance and delivery to your door, with duties and taxes paid by us; we will confirm the DDP rate based on your postcode. Documents provided with each shipment: commercial invoice, packing list, bill of lading or airway bill, certificate of analysis, material safety data sheet (MSDS) if applicable, free-sale certificate, and phytosanitary certificate for plant-derived prebiotics where required by the destination country.

For prebiotic capsules, the MSDS is usually not required for air freight as they are not classified as dangerous goods. However, some carriers request a non-hazardous declaration, which we provide. We also provide a certificate of origin for countries with preferential tariffs. Payment terms are 30% deposit, 70% before shipment, or a letter of credit at sight for orders above 20,000 units. All lead times are estimates and confirmed at order acceptance.