Our ISO-Certified & GMP-Compliant Facility我們的 ISO 認證及 GMP 合規生產設施
Quality and compliance are at the core of Beautech's manufacturing capabilities. Our facility is FDA registered, cGMP and ISO 22716 certified, meeting global standards for cosmetic production. Equipped with an ISO Class 8 cleanroom (ISO 14644-1:2015) and two-stage RO + EDI purified water held below 0.1 µS/cm, our skilled engineering team delivers flexible manufacturing solutions, meticulous product care, and punctual batch fulfillment to support your market growth.品質與合規是美科生產實力的核心。廠房已於美國 FDA 登記,並取得 cGMP 及 ISO 22716 認證,符合國際化妝品生產標準。配備 ISO Class 8 潔淨車間(ISO 14644-1:2015)及兩段式 RO + EDI 純水系統(導電度維持在 0.1 µS/cm 以下),我們的工程團隊提供靈活的生產方案、嚴謹的產品照護及準時的批次交付,支持你的市場拓展。
- 01Compounding room — Vacuum Homogenizers and RO & EDI water purification, with ionic conductivity held below 0.1 µS/cm.配料室 — 真空均質機及 RO + EDI 純水系統,離子導電度維持在 0.1 µS/cm 以下。
- 02Cleanroom — automated double-jet filling, capping and sealing lines, 100ml–1000ml, running under GMP control.潔淨車間 — 自動雙頭灌裝、封蓋及封口生產線,100ml–1000ml,於 GMP 管控下運行。
- 03Filling — ceramic precision filling, 1ml–50ml, and capping.灌裝 — 陶瓷精密灌裝,1ml–50ml,及封蓋。
- 04Packing — secondary packing, labelling and boxing of finished goods.包裝 — 成品的二次包裝、貼標及裝箱。
End-to-end production
under one roof端到端生產能力
集於一站完成
All twelve stages below — from mixing to master-carton packing — run in-house in the ISO Class 8 cleanroom under cGMP #HBPCER20260264. Batch consistency rests on two controls that apply to every run: RO + EDI water held below 0.1 µS/cm, and the five-category QC release panel.以下十二個工序 — 由混合到外箱包裝 — 全部在 ISO Class 8 潔淨車間內按 cGMP #HBPCER20260264 自家完成。批次一致性建基於兩項適用於每批生產的管控:導電度維持在 0.1 µS/cm 以下的 RO + EDI 純水,以及五類品檢放行程序。
Mixing攪拌
Advanced vacuum homogenization for stable emulsions先進真空均質技術,確保乳化穩定
Cleaning & Washing清洗
Air blowing and bottle washing氣吹及樽身清洗
Sanitizing消毒
Four-tier sterilization — oven, ozone, UV, alcohol四重滅菌 — 焗爐、臭氧、紫外線、酒精
Filling灌裝
Precision dispensing for jars, bottles, tubes, vials, sachets and ampoules精準灌裝罐、樽、軟管、瓶、小包裝及安瓶
In-house Lab Testing自設化驗
Multi-point QC testing and compliance verification多點品質檢測及合規驗證
Capping旋蓋
High-speed automated capping and closure alignment高速自動旋蓋及封蓋對位
Sealing封口
Tamper-evident thermal and induction sealing防偽熱封及感應封口
Labelling貼標
Accurate, high-speed label application精準高速貼標
Boxing入盒
Automated primary and secondary boxing自動初級及二級入盒
Encoding打碼
Industrial batch, lot and expiry ink-jet printing工業噴碼標示批號、批次及有效期
Shrink Wrapping收縮包裝
Durable outer protective film wrapping耐用外層保護膜包裝
Packing裝箱
Final master carton packing, palletizing and shipping prep最終大箱包裝、疊板及付運準備
Unidirectional workflow
for maximum purity單向流程
確保最高潔淨度
Our plant layout is meticulously zoned to adhere to strict international GMP design concepts. By enforcing a strict one-way operational pathway, we maintain total environmental control from raw material receipt to final dispatch.我們的廠房佈局按嚴格的國際 GMP 設計理念悉心分區。透過執行嚴格的單向作業流程,我們從原料接收到最終付運,全程維持完全的環境控制。
R&D Laboratory研發實驗室
Specialized testing and custom formulation development — technicians conduct structural stability validation to ensure a seamless transition from bench to bulk.專項測試及訂製配方研發 — 技術人員進行結構穩定性驗證,確保由小樣到大貨的過程順暢銜接。
Material Intake & Weighing物料接收及秤量
Strict intake protocols featuring isolation quarantine, chemical identity verification, and ultra-accurate dispensing against batch master sheets.嚴格的接收程序,包括隔離檢疫、化學成分核對,以及按批次總表進行極精準配料。
Compounding調配生產
Advanced blending utilizing automated temperature controls and high-shear mixers to consistently meet formulation viscosity and structural parameters.先進調配技術,配合自動溫控及高剪切攪拌機,穩定達到配方黏度及結構參數要求。
Filling & Packaging灌裝及包裝
Flexible, multi-tiered lines supporting diverse packaging profiles — airless pumps, sachets, tubes and vials — integrated with various packaging needs.靈活多層生產線,支援真空泵、小包裝、軟管及瓶裝等多種包裝形式,配合不同包裝需求。
Quality Control品質控制
End-of-line verification including analytical microbiology, packaging leak tests, and final regulatory sign-off for market-ready inventory.生產線末端檢驗,包括分析微生物測試、包裝滲漏測試,以及最終法規放行,確保貨品可供上市。
Cleanroom-grade infrastructure
globally compliant operations潔淨車間級基建
全球合規營運
We de-risk your global supply chain by enforcing stringent quality protocols that align with the world's most rigorous cosmetic GMP directives. Manufacturing takes place within highly controlled, certified cleanroom environments engineered to meet international regulatory benchmarks.我們執行嚴格的品質協議,符合全球最嚴謹的化妝品 GMP 指引,為你的全球供應鏈降低風險。生產於高度受控、經認證的潔淨車間內進行,達到國際監管基準。
Registered已登記
Compliant符合標準
ISO 14644-1:2015 (Class 100,000, FED STD 209E)ISO 14644-1:2015(相當於 FED STD 209E Class 100,000)
Buyer-registered products; export documentation prepared由買家完成產品註冊,本廠提供出口文件
Continuous cleanroom monitoring持續潔淨車間監控
Production runs in an ISO Class 8 cleanroom (ISO 14644-1:2015), equivalent to Class 100,000 under FED STD 209E. Environmental integrity is maintained by active laser particle counting alongside automated HVAC control of humidity, temperature and differential air pressure.生產於 ISO Class 8 潔淨車間(ISO 14644-1:2015)內進行,相當於 FED STD 209E 的 Class 100,000。透過主動激光粒子計數,配合自動化 HVAC 系統監控濕度、溫度及氣壓差,維持環境完整性。
Type II pure water — RO + EDI, below 0.1 µS/cmType II 純水 — RO + EDI,低於 0.1 µS/cm
Formulations are built on Type II pure water. A two-stage Reverse Osmosis and Electro-Deionisation (EDI) system continuously removes trace ions and holds conductivity below 0.1 µS/cm; because EDI regenerates electronically, without chemical recharging, water quality does not drift between production days.配方以 Type II 純水為基礎。兩段式逆滲透(RO)配合電去離子(EDI)系統持續移除微量離子,將導電度維持在 0.1 µS/cm 以下;EDI 以電力自我再生、無需化學再生劑,水質不會因生產日而漂移。
Ingredient policy原料政策
No animal testing. Raw materials are screened against the regulatory ingredient limits of each target market (US, China, ASEAN), and every Beautech formulation is developed free from parabens, MIT, mineral oil, heavy metals, hormones and known irritants.不進行動物測試。原料按各目標市場(美國、中國、東盟)的法規成分限值篩選;美科所有配方均不含 parabens、MIT、礦物油、重金屬、激素及已知刺激物。
Documented traceability
at every stage每個階段
均有據可查
Incoming material QC來料品檢
Stringent chemical identity validation and screening of raw materials prior to production deployment.嚴格的化學成分驗證及原料篩查,於投產前完成。
In-process control製程控制
Real-time engineering checks tracking batch viscosity, pH and appearance against strict baseline specifications.即時工程檢測,按嚴格基準規格追蹤批次黏度、pH 及外觀。
Micro & stability testing微生物及穩定性測試
Analytical microbiological screening and shelf-life stress tests to validate safety, preservation efficacy and formula stability.分析性微生物篩查及保質期壓力測試,驗證安全性、防腐功效及配方穩定性。
Final release最終放行
Comprehensive finished-product audit accompanied by fully traceable batch manufacturing documentation and a verified CoA.全面成品審核,附完整可追溯的生產批次文件及經核實的 CoA。
Transparent terms
Reliable execution條款透明
執行可靠
Per SKU每個 SKU 計算
In-house formula · ~19 wks custom自家配方 · 客製配方約 19 週
Proven, market-tested bases經市場驗證的基底
GMP certified productionGMP 認證生產
