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GMP Cleanroom & QC Lab Standards for OEM Batch ConsistencyGMP潔淨室、純水系統與QC化驗室:OEM代工批次一致性標準

4 min read閱讀約 4 分鐘Beautech Journal美科專欄

Beautech is a cGMP (#SZ2306D2) and ISO 22716 (#SZ2306D1) certified OEM/ODM manufacturer in Hong Kong. Batch-to-batch consistency — from a small sample to full production — rests on three controls: an ISO Class 8 cleanroom, a two-stage RO+EDI Type II water system, and an in-house QC lab that tests physical, microbial and stability parameters on every production run.美科是香港的 OEM/ODM 護膚品及化妝品代工廠,持有 cGMP(#SZ2306D2)及 ISO 22716(#SZ2306D1)認證。無論由小量試樣到正式大貨生產,批次與批次之間的一致性,均建基於三項管控:ISO Class 8 潔淨室、兩級 RO 逆滲透加 EDI 純化系統,以及每個生產批次均會進行物理、微生物及穩定性檢測的自設品管化驗室。

01 · CLEANROOM01 · 潔淨室
ISO Class 8
ISO 14644-1:2015
02 · WATER02 · 純水系統
RO + EDI
< 0.1 µS
03 · QC LAB03 · 品管化驗室
5 test categories5 項檢測
Every batch每個批次
04 · R&D04 · 研發
Concept → batch概念至批次
6–8 / ~19 wks

Certifications: The Standards Behind Every Batch認證資格:每批次背後的標準依據

Beautech holds four registrations a buyer can verify independently: Factory Registration FR#41165, cGMP certificate #SZ2306D2, ISO 22716 certificate #SZ2306D1, and FDA FEI #3014467688. The production cleanroom is classified ISO Class 8 under ISO 14644-1:2015 (equivalent to Class 100,000 under FED STD 209E). These four numbers, together with the cleanroom classification, are the baseline the cleanroom, water system and QC lab sections below are built on — every claim in this article traces back to one of them.美科持有四項可供買家獨立核實的登記資料:廠房登記 FR#41165、cGMP 證書 #SZ2306D2、ISO 22716 證書 #SZ2306D1,以及美國 FDA FEI 編號 #3014467688。生產潔淨室依 ISO 14644-1:2015 標準評為 ISO Class 8(相當於 FED STD 209E 標準下的 Class 100,000)。以上四項編號連同潔淨室等級,是本文以下潔淨室、純水系統及品管化驗室三部分內容的依據 — 文中每項陳述均可追溯至其中之一。

Cleanroom: ISO Class 8 Manufacturing Environment潔淨室:ISO Class 8 生產環境

Beautech's production cleanroom is classified ISO Class 8 (ISO 14644-1:2015), equivalent to Class 100,000 under the older FED STD 209E standard — a controlled environment that limits airborne particles and contamination during mixing, filling and packing. Manufacturing inside a classified cleanroom, rather than an open production floor, is one of the conditions cGMP #SZ2306D2 and ISO 22716 #SZ2306D1 certification audits against. For a buyer, the practical effect is fewer environmental variables between the day a sample is mixed and the day a 1,000-unit production run is filled — one fewer reason bulk output should drift from what was approved.美科生產潔淨室依 ISO 14644-1:2015 標準評為 ISO Class 8,相當於舊制 FED STD 209E 標準下的 Class 100,000 — 屬受控環境,在混合、灌裝及包裝過程中限制空氣中懸浮粒子及污染物。在已分級的潔淨室內生產,而非於開放式廠房作業,正是 cGMP #SZ2306D2 及 ISO 22716 #SZ2306D1 認證審核的其中一項要求。對買家而言,這代表由試樣調配當日,到 1,000 件起訂量的正式生產當日,環境變數大幅減少 — 令大貨與確認樣品出現偏差的其中一個風險因素得以消除。

Water System: Two-Stage RO + EDI Purification純水系統:兩級 RO 逆滲透 + EDI 純化

Every formula at Beautech is built on Type II Pure Water, produced by a two-stage Reverse Osmosis (RO) and Electro-De-Ionization (EDI) system that continuously removes trace ions and holds ionic conductivity below 0.1 µS. Because the EDI stage regenerates itself electronically — without the harsh regenerant chemicals a resin-based system needs — water quality does not fluctuate between production days. In practice, the water going into batch one and the water going into batch fifty meet an identical standard, which supports consistent efficacy, extended shelf life, and compliance with pharma-, cosmetics- and biotech-grade water requirements on every run.美科所有配方均以 Type II 純水為基礎,經兩級逆滲透(RO)及電去離子(EDI)系統處理,持續去除水中微量離子,離子導電度維持於 0.1 µS 以下。由於 EDI 系統以電子方式自我再生,毋須使用傳統樹脂系統所需的強酸強鹼再生藥劑,水質不會因生產日子不同而出現波動。換言之,第一批貨與第五十批貨所使用的水,均達到完全相同的標準 — 有助確保功效穩定、延長產品保存期,並符合藥業、化妝品及生物科技級別對用水的嚴格要求。

QC Lab: Batch Testing on Every Production Run品管化驗室:每個生產批次均須檢測

Before a batch ships, Beautech's in-house QC lab runs five categories of tests on every production run:貨品出貨前,美科的自設品管化驗室會對每個生產批次進行五類檢測:

Physical evaluation物理性狀評估
pH, viscosity, density, appearance, colour and odour.pH 值、黏度、密度、外觀、顏色及氣味。
Microbial testing微生物檢測
Total microbial count, E. coli count, mould & yeast count.總菌落數、大腸桿菌數、黴菌及酵母菌數。
Container compatibility容器相容性測試
Checked for leaking and any colour, odour or shape change.檢查有否滲漏及顏色、氣味或形狀變化。
Centrifuge test離心測試
Verifies emulsion stability under forced separation.驗證乳化穩定性。
Accelerated stability加速穩定性測試
Projects shelf life under elevated stress conditions.用以推算保存期限。

Every order ships with a Certificate of Analysis (CoA), an MSDS and an internal stability report as standard; a Free Sales Certificate, third-party certification and organisation authentications are available on request for an additional fee. This is the direct answer to "will the bulk production match the sample?": the same five test categories that clear a batch for shipment are what a buyer can request data against.每張訂單均按標準隨附成分檢驗報告(CoA)、安全數據表(MSDS)及內部穩定性報告;如需自由銷售證明書、第三方認證或機構認證文件,可按要求另行收費提供。這正正回答了買家最常問的問題 —「大貨是否與確認樣品一致?」:批准出貨所依據的五類檢測,正是買家可要求索取數據作核對的項目。

R&D and Custom Formulation: From Concept to Production Batch研發與訂製配方:由概念到正式生產批次

Beautech maintains in-house R&D and a formulation lab, supporting both fully custom formulations and adaptations of an existing in-house formula. For a custom formulation, the process runs roughly 19 weeks in total: about 2 weeks for R&D and prototyping, around 13 weeks for accelerated stability and PET testing, and about 4 weeks for production; in-house (existing) formulas run 6-8 weeks instead. Before formulation begins, both sides sign a mutual NDA and agree briefing documentation that locks in the target texture, scent, colour and performance — the same benchmark the QC lab later checks the finished batch against. R&D/prototype sample charges are collected once both parties confirm the development project; bulk orders are billed 50% advance, with the balance due after production is completed. Because the cleanroom, water system and QC lab apply the same controls to the 1,000-unit minimum order as to every batch after it, the formula approved at sampling stage is the formula shipped at production stage.美科設有自設研發部門及配方化驗室,既可開發全新訂製配方,亦可因應現有配方作調整。以訂製配方為例,整個流程約需 19 週:約 2 週用於研發及製作原型、約 13 週進行加速穩定性測試及 PET 測試、約 4 週用於正式生產;如採用現有配方,則只需 6 至 8 週。配方開發展開前,雙方會簽署互相保密協議(NDA),並確認簡報文件,訂明質地、香味、顏色及功效等目標 — 這亦是品管化驗室日後檢驗成品時所依據的基準。研發/試樣費用於雙方確認開發項目後收取;大貨訂單則按落單時收取 50% 訂金,餘款於生產完成後結清。由於潔淨室、純水系統及品管化驗室對 1,000 件起訂量的每一批次均採用同一套標準,試樣階段所確認的配方,就是正式投產時所交付的配方。

Looking to develop or scale a skincare product?正考慮開發或擴大護膚品生產? Beautech takes you from concept to finished, market-ready goods. Start a project開始合作
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