Thermo Scientific RX10050 藥品金屬檢測系統
Detects metal contamination in bulk flow tablets or capsules to facilitate pharmaceutical GMP
Assists in compliance with GMPs in 21 CFR parts 210 and 211
Complete system makes installation quick and easyStraight-through flow prevents product damage
Up to 500 K/hour tablet or capsule throughput
High frequency and gain operation to detect metal fragments as small as 0.3 mm
Rated for IP65 wash down and dust resistance
Easily set up with autolearn function and multilingual help text
Multi-level password protection ensures correct operation in production
Fe, non-Fe, and 316 stainless steel test disks included
This high-performance, complete metal detection system is designed to meet the exacting demands of the pharmaceutical industry. When installed on the output of a tablet press, deduster, or capsule filler, the unit will ensure the absence of even small slivers of metal, providing the highest sensitivity possible at high flow rates—while preventing product damage.
The APEX 500 Rx features a patented multicoil design that consistently delivers industry-leading sensitivity and stability, but is not impacted by product effects or environmental changes. Manufactured to meet the U.S. Federal Drug Administration’s (FDA) stringent requirements for validated production, this unit uses only FDA-compliant materials in all areas of the system that come in contact with the product.
This flexible system is completely mobile and designed for fast disassembly and cleaning. Intuitive icon-driven interface and step-by-step quick-reference guide make this system easy to set up, program, and operate—without any additional training needed.
Featured Total Quality Solution (TQS) package continuously monitors and validates the system’s performance to eliminate costly recalls and quarantines. Expand on the validation protocol by ordering the optional patented Thermo Scientific AuditCheck? verification system. With AuditCheck, you don’t need to perform manual testing to ensure high performance. Additional accessories include communication modules, high-polish finish, and IQ/OQ/PQ validation package to assist with FDA compliance.
What's Included:
metal detector head, height/angle-adjustable stand with locking casters, complete fail-safe pneumatic rejecter system, test disks, and documentation on CD (users’ guides and installation instructions, quick-reference guide, and PC software simulator)
Specifications | ||
Product Type | Pharmaceutical Metal Detection Systems | |
Operating conditions | 14 to 104°F (-10 to 40°C), 20 to 80% RH noncondensing | |
Power | 85 to 260 VAC single phase plus earth ground 47 to 65 Hz, 100 watts max | |
Outputs | Six relays: 250 VAC, 2 A max; 50 VDC, 1 A max | |
Output allocation | (Selectable via menu) Reject 1, reject 2, fault, alarm, warning, QA lamp | |
Inputs | Six: active 12 VDC + 12 V auxiliary supply for input sensors | |
Input allocation | (Selectable via menu) Speed sensor, keylock, product select 1, product select 2, infeed PEC, reject confirmation 1 (bin full), reject confirmation 2, external suppression | |
Construction | 304 stainless steel straightlined case (high polish optional). All plastics used are FDA approved | |
Protection ratings | IP 65, ATEX zone 22, hazardous location Class II, Division 2, Groups F & G head and electronics only | |
Languages | English, Spanish, French, German, Italian, Dutch, Chinese, Russian, Czech, Polish | |
Air supply | 5.5 bar (80 psi) nominal, 4 bar (60 psi) minimum | |
Product speed | 1.7 to 3300 ft/min (0.5 to 1000 m/min) | |
CE Compliance | Yes | |
Manufacturer number | RX10050 | |
Brand | Thermo Scientific |
促進藥品GMP檢測金屬污染的散流片或膠囊
協助符合GMP要求的21 CFR部分210和211
完整的系統,使安裝方便快捷
直通流防止產品損壞
高達500 K /小時片劑或膠囊吞吐量
高頻率和增益的操作,以檢測為0.3毫米的小的金屬碎片
額定IP65洗性和防塵
輕松設置與autoLearn的功能和多語種的說明文字
多級密碼保護,確保在生產中的正確操作
包括鐵,非鐵,和316不銹鋼測試磁盤
這種高性能,完整的金屬檢測系統是專為滿足制藥行業的嚴格要求。當安裝在壓片機,除塵器,或膠囊填充板的輸出,單位將確保的情況下,即使是很小的金屬條子,提供最高的靈敏度可在高流速,同時防止產品損壞。APEX 500 RX設有一個的專利multicoil設計,一直致力于提供業界領先的靈敏度和穩定性,但不影響產品效果或環境的變化。制造滿足美國聯邦藥物管理局(FDA)認可生產的嚴格要求,本機使用的系統與產品接觸的所有領域只有符合FDA標準的材料,這種靈活的系統是完全移動和快速拆裝設計和清潔。直觀的圖標驅動的界面和漸次快速參考指南使這個系統容易來設置起來,程序,和操作,而不需要任何額外的培訓。精選全面質量方案(TQS)包不斷監測和驗證系統的性能,以消除昂貴的召回和隔離。擴展驗證協議訂購可選的專利Thermo Scientific的的的AuditCheck?驗證系統。使用的AuditCheck,你不需要進行手動測試,以確保高性能。其他配件包括通信模塊,高度拋光處理,和IQ / OQ / PQ驗證方案,協助符合FDA 包含什么:金屬探測器頭,鎖腳輪,完整的故障安全氣動拒收系統的高度/角度可調支架,測試磁盤,光盤上的文檔(用戶指南和安裝說明書,快速參考指南,以及PC軟件模擬器)
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產品規格 | ||
產品類型 | 藥品金屬檢測系統 | |
工作條件 | 14至104°F(-10至40°C),20?80%RH,無冷凝 | |
功率 | 85到260 VAC單相帶地線47至65赫茲,100瓦最大 | |
輸出 | 六個繼電器:250 VAC,2 A最大50 VDC,1 A最大 | |
輸出分配 | (通過菜單選擇)拒絕1,拒絕2,故障,報警,預警,QA燈 | |
輸入 | 六:活躍的12 VDC + 12 V輔助電源為輸入傳感器 | |
輸入分配 | (通過菜單選擇)速度傳感器,鎖,產品選擇,產品選擇1 2,進給PEC,拒絕確認1(箱滿),拒絕確認2,外部抑制 | |
施工 | 304不銹鋼straightlined的情況下(高拋光可選)。所有塑料使用FDA批準 | |
防護等級 | ATEX區域22,IP 65,II類危險場所,2區,F和G組頭和電子只 | |
語言 | 英語,西班牙語,法語,德語,意大利語,荷蘭語,漢語,俄語,捷克語,波蘭語 | |
供氣 | 5.5巴(80 psi)的名義,至少4巴(60磅) | |
產品速度 | 1.7至3300英尺/分鐘(0.5?1000米/分) | |
符合CE認證 | 是 | |
制造商數量 | RX10050 | |
牌 | Thermo Scientific |
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