WhiteningBright
Company

Our Production Facility

Production capacity, facility certifications, audit cadence.

Production is centralized at our 6,000m² facility in Shenzhen. The plant runs six dedicated lines for whitening kits, pens, strips, powders, pastes and oral-care devices. This page documents the facility's capacity, equipment and quality workflow at the level customer audits expect.

Production facility, Shenzhen - main floor view
Main production floor, Shenzhen - 6,000 m² across six dedicated lines.
6,000m²facility
6Production lines
500KUnits/month capacity
100KCleanroom class

Facility overview

The plant is organized into four functional zones: production (six lines), R&D, quality control, and warehouse. Each zone is staffed and audited independently. Material flow runs uni-directionally - raw materials enter at the warehouse, exit at the shipping dock - to keep cross-contamination risk low.

Zone Function Notes
Production hall Six dedicated lines - gel, strips, powder, paste, devices, pens Class 100,000 cleanroom for gel filling and primary packaging
R&D laboratory Formulation development, stability testing, accelerated aging studies PhD-led team; 240+ active formulations on file
QC laboratory Incoming raw material testing, in-process sampling, finished goods release Microbiological, pH, viscosity, active concentration assays
Warehouse Raw material and finished goods storage 1,500 m² FIFO inventory climate controlled for active ingredients

Production lines

The figures below are sustained daily output, not peak capability. Lead times include in-line QC and pre-shipment inspection.

Line Daily capacity Production lead time
Whitening kits (gel + LED accelerator) 15,000 units 15-20 days
Whitening pens & syringes 30,000 units 10-15 days
Whitening strips 50,000 units 20-25 days
Powders & pastes 20,000 units 10-20 days
Electric oral-care devices 8,000 units 20-25 days
LED accelerator lights (standalone) 5,000 units 15-20 days
Gel filling line in operation
Gel filling line - primary packaging stage.
Pen and syringe filling line
Pen and applicator filling line.
Workshop floor under ISO 13485
Workshop floor - operates under ISO 13485.

Equipment

  1. Automatic gel fillers

    2% volume accuracy across the production run, verified by hourly fill-weight checks.

  2. Inline vision inspection

    Camera-based defect detection at the carton-seal station; reject rate logged to the batch record.

  3. Ultrasonic sealing

    Used for syringes and pen applicators where heat sealing would compromise the active. Seal-integrity samples pulled per AQL 1.5.

  4. HEPA-filtered air handling

    Class 100,000 in primary packaging zones. Differential pressure monitored continuously; logs available with batch records.

Quality workflow

  1. Raw material verification

    Certificate of Analysis review on receipt, plus in-house assay (active concentration, microbiological) before release to production.

  2. In-process control

    pH, viscosity and active concentration measured at fixed intervals throughout the production run. Out-of-spec readings trigger line stop and root-cause investigation.

  3. Pre-shipment release

    Visual, dimensional and functional checks at AQL 1.5 / 2.5 / 4.0 levels depending on customer specification.

  4. Documentation and retention

    Batch record, retain samples and Certificate of Analysis archived; copies supplied to customer with each shipment.

QC stability and assay testing
QC lab - stability and assay testing.
Class 100,000 cleanroom
Class 100,000 cleanroom - upgraded in 2023.

Audits and customer visits

The plant hosts third-party audits on a six-month cadence (SGS, Intertek, BSCI, SEDEX). Customer-specific audits are scheduled separately and we provide access to the lot records, supplier traceability and audit reports that the auditing team requires.

Visit type Format
Virtual factory tour Live video walk-through of production floor, R&D and QC labs - 30 minutes, scheduled by appointment.
On-site customer visit Shenzhen facility, by appointment. Visa support letter issued on request. Travel from SZX airport is ~45 minutes by car.
Third-party audit SGS, Intertek, BSCI, SEDEX, or customer-nominated auditor. Audit pack (procedures, batch records, supplier list) prepared in advance.
Audit documentation. Past audit reports (BSCI, SEDEX SMETA, third-party SGS) are available to active customers under NDA.

Request manufacturing information

Specifications, pricing, lead times — typical response within one business day.

Contact sales