GMP-compliant tube filling machines for pharmaceutical ointments, gels, and cosmetic creams. Dual-industry design serves both pharma and cosmetics contract manufacturers.
Pharmaceutical and cosmetics manufacturers share a common need: safe, precise, and compliant tube packaging. YohoAI's YG series tube filling machines are designed from the ground up to meet both pharmaceutical GMP and cosmetic industry standards on the same platform. The same machine that fills prescription ointments can fill cosmetic night creams - with no cross-contamination risk and full lot traceability. For pharmaceutical factories, the YG series supports IQ/OQ/PQ validation, 21 CFR Part 11 data logging, and nitrogen flushing for oxygen-sensitive formulations. For cosmetics manufacturers, the same machine offers the throughput and format flexibility needed for seasonal product launches and promotional volumes.
Verified factory data - not marketing estimates
IQ/OQ/PQ validation documentation packages available. Design qualification, installation qualification, operational qualification, and performance qualification protocols prepared by our validation team. FAT video provided.
Format changeover in 20-45 minutes with no tools. Recipe storage for up to 200 tube formats on the HMI. Ideal for cosmetics manufacturers running multiple SKUs and seasonal product lines.
Enclosed product circuit with no dead legs. Product contact surfaces are 304 stainless steel (316L optional). All seals are food/pharma grade. Clean-in-place (CIP) and sterilize-in-place (SIP) protocols validated.
Factory-installed nitrogen flushing system reduces headspace oxygen to below 1% for oxidation-sensitive formulations (certain vitamins, natural plant extracts, alpha-hydroxy acids). Essential for premium pharmaceutical ointments.
Every fill is logged with timestamp, batch number, operator ID, and fill volume. Data exportable via USB or Ethernet. Lot number printing via thermal transfer or inkjet coder. Reject records maintained for regulatory audits.
Every filled tube passes through an in-line checkweigher. Under-filled and over-filled tubes are automatically rejected and logged. Statistical process control (SPC) data available for process improvement and regulatory compliance.
Our team responds within 2 hours with CIF/CFR/FOB pricing and delivery timeline.
All YG series machines carry CE marking and are designed to comply with cGMP (current Good Manufacturing Practice) and ISO9001 quality management standards. For pharmaceutical customers, IQ/OQ/PQ validation protocols are available as an add-on. Documentation is prepared to support FDA, EMA, and NMPA regulatory submissions.
Yes. The YG series is a dual-industry platform. Pharmaceutical and cosmetics manufacturers frequently share the same machine model - the key differentiator is the validation package and optional accessories (nitrogen flushing, 21 CFR Part 11 data logging). The CIP/SIP cleaning protocol validated for pharmaceutical products also meets cosmetic industry hygiene standards.
YohoAI provides a comprehensive IQ/OQ/PQ documentation package prepared by our in-house validation engineer. This includes: DQ (Design Qualification) document, IQ (Installation Qualification) checklist, OQ (Operational Qualification) test protocols with acceptance criteria, and PQ (Performance Qualification) protocol. The package is available in English. On-site IQ/OQ/PQ execution support is available on request.
Standard pharmaceutical tube sizes range from 13mm to 40mm diameter and 40mm to 150mm length. For ophthalmic (eye) preparations, 10mm diameter tubes are available. The YG series accommodates the full pharmaceutical tube size range. Non-standard sizes can be accommodated with custom tube holder tooling (typically 2-3 weeks additional lead time).
The YG series is CIP/SIP compatible. Clean-in-place uses a validated 3-step protocol (water rinse, alkaline wash, water rinse). Sterilize-in-place uses steam at 121 degC for 20 minutes (SIP port standard on pharma configuration). Cleaning validation protocols are included in the IQ/OQ/PQ documentation package. For cosmetic products with pigment or fragrance, additional cleaning validation may be required.
The YG-120 in pharmaceutical GMP configuration (316L SS, nitrogen flushing, 21 CFR Part 11, IQ/OQ/PQ docs) is quoted per project. The YG-200 pharma configuration is quoted per project. Prices vary based on specific accessories and validation scope. A detailed quotation is provided within 2 hours of inquiry.
Yes. YohoAI's Shanghai demo facility can process your actual product or a representative formulation. We can fill sample tubes and ship them to you for quality assessment. Demo sessions are typically arranged within 5 working days of inquiry. Video recording of the demo run is provided for internal evaluation.
Recommended spare parts inventory: sealing plates (replace every 3-6 months at high volume), tube holder wear rings (every 6-12 months), pump seals and O-rings (every 6 months), V-belts/timing belts (every 12 months). YohoAI offers annual spare parts kits at discounted rates. All standard spare parts ship from Shanghai within 48 hours. Emergency air freight delivery is available within 3-5 days globally.
Pharmaceutical tube filling requires strict adherence to GMP guidelines. The machine must be installed in a cleanroom environment (ISO 7 minimum) with controlled temperature (18-25 deg C) and humidity (below 60% RH). All product-contact surfaces are 316L stainless steel with Ra < 0.4 um finish, and the machine includes CIP (Clean-in-Place) connections for validated cleaning between batches.
Validation protocols include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. Maintain batch records per 21 CFR Part 11 requirements, including electronic signatures and audit trails. The filling system must be calibrated before each batch, and seal integrity testing (squeeze test, leak test) must be performed on the first 3 tubes of each batch.
Preventive maintenance follows a risk-based schedule: daily cleaning and sanitization of product-contact parts, weekly inspection of sealing jaw alignment and ultrasonic horn condition, and monthly calibration of filling volume and pressure sensors. Annual maintenance should include a full machine qualification review and replacement of all critical O-rings and seals.
Built to hygienic and regulatory standards from the frame up
The pharma-cosmetics tube filler is built to hygienic and regulatory standards from the frame up. Product-contact parts are 316L stainless steel with an Ra < 0.4 um electropolished finish, while the 304 SS frame is sealed and easy to wipe down in an ISO 7 (Class 10,000) clean environment. Dosing uses servo volumetric pistons covering 5-250 ml (YG-120) and 10-250 ml (YG-200) at +/-1% and +/-0.5% accuracy, verified by in-line checkweighing and recorded to batch logs. The sealing station supports hot-air plus cold-press (YG-120) or hot-air plus ultrasonic (YG-200) for ABL, PBL, and extruded tubes. A colour HMI stores up to 200 recipes and enforces parameter limits, and optional nitrogen flushing protects oxygen-sensitive actives during filling. All gaskets are FDA/EP compliant and the machine is supplied with IQ/OQ/PQ protocols.
Three regulatory tiers on one platform
The same platform is tuned to three regulatory tiers. Pharmaceutical builds use 316L, Ra < 0.4 um, ISO 7 clean-room class, full IQ/OQ/PQ validation, and 21 CFR Part 11 electronic batch records - carrying a roughly 25% premium. Cosmetic builds use 304 SS, Ra < 0.8 um, ISO 8 class, IQ/OQ validation, and standard batch records at base price. Food builds use 304 SS, Ra < 1.6 um, ISO 9, functional validation only. Sealing differs too: pharma favours hot-air plus ultrasonic for laminate barrier tubes, while cosmetic and food lines use hot-air crimp. Choosing the correct tier avoids over-validating a cosmetic line or under-specifying a pharma one; YohoAI documents the delta so quality teams can justify the configuration to auditors without redundant expenditure.
Hygienic maintenance protects product and compliance
Hygienic maintenance protects both product and compliance. Between batches, fully CIP-rinse and, where needed, SIP the product-contact path; disassembly uses tool-free clamps so operators reach every surface. Daily: verify seal-head cleanliness, lubricator level, and run five test tubes. Weekly: inspect gaskets and O-rings for wear or residue, and confirm photoelectric registration after artwork changes. Monthly: replace sealing plates per volume, lubricate servo rails, and recalibrate dosing, logging each step to the batch record. Annual: requalify the line with an abbreviated IQ/OQ review and back up HMI recipes. YohoAI supplies a pharma spare kit (seals, pistons, O-rings, belts) from Shanghai within 48 hours, and service contracts include two engineer visits plus remote diagnostics to keep validation status intact.
First-visit audit pass for a prescription cream
A European dermatology brand qualified a YG-120 pharma build to fill a prescription 30 ml cream in ABL tubes at 60 pcs/min with +/-1% accuracy. The 316L, Ra < 0.4 um contact path and IQ/OQ/PQ package passed the client's supplier audit on the first visit, and 21 CFR Part 11 batch logging met their pharmacovigilance requirements. Nitrogen flushing at the fill head kept an oxygen-sensitive active stable, extending shelf life by six months versus the previous contract filler. After 12 months the line recorded zero fill-weight deviations and 98% OEE; the brand subsequently migrated two more SKUs onto the same machine using stored recipes, avoiding a second capital purchase and shortening time-to-market for line extensions.
