Thermo Scientific RX10050 药品金属检测系统
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 |
促进药品GMP检测金属污染的散流片或胶囊
协助符合GMP要求的21 CFR部分210和211
完整的系统,使安装方便快捷
直通流防止产品损坏
高达500 K /小时片剂或胶囊吞吐量
高频率和增益的操作,以检测为0.3毫米的小的金属碎片
额定IP65洗性和防尘
轻松设置与autoLearn的功能和多语种的说明文字
多级密码保护,确保在生产中的正确操作
包括铁,非铁,和316不锈钢测试磁盘
这种高性能,完整的金属检测系统是专为满足制药行业的严格要求。当安装在压片机,除尘器,或胶囊填充板的输出,单位将确保的情况下,即使是很小的金属条子,提供最高的灵敏度可在高流速,同时防止产品损坏。APEX 500 RX设有一个的专利multicoil设计,一直致力于提供业界领先的灵敏度和稳定性,但不影响产品效果或环境的变化。制造满足美国联邦药物管理局(FDA)认可生产的严格要求,本机使用的系统与产品接触的所有领域只有符合FDA标准的材料,这种灵活的系统是完全移动和快速拆装设计和清洁。直观的图标驱动的界面和渐次快速参考指南使这个系统容易来设置起来,程序,和操作,而不需要任何额外的培训。精选全面质量方案(TQS)包不断监测和验证系统的性能,以消除昂贵的召回和隔离。扩展验证协议订购可选的专利Thermo Scientific的的的AuditCheck™验证系统。使用的AuditCheck,你不需要进行手动测试,以确保高性能。其他配件包括通信模块,高度抛光处理,和IQ / OQ / PQ验证方案,协助符合FDA 包含什么:金属探测器头,锁脚轮,完整的故障安全气动拒收系统的高度/角度可调支架,测试磁盘,光盘上的文档(用户指南和安装说明书,快速参考指南,以及PC软件模拟器)
产品规格 | ||
产品类型 | 药品金属检测系统 | |
工作条件 | 14至104°F(-10至40°C),20〜80%RH,无冷凝 | |
功率 | 85到260 VAC单相带地线47至65赫兹,100瓦最大 | |
输出 | 六个继电器:250 VAC,2 A最大50 VDC,1 A最大 | |
输出分配 | (通过菜单选择)拒绝1,拒绝2,故障,报警,预警,QA灯 | |
输入 | 六:活跃的12 VDC + 12 V辅助电源为输入传感器 | |
输入分配 | (通过菜单选择)速度传感器,锁,产品选择,产品选择1 2,进给PEC,拒绝确认1(箱满),拒绝确认2,外部抑制 | |
施工 | 304不锈钢straightlined的情况下(高抛光可选)。所有塑料使用FDA批准 | |
防护等级 | ATEX区域22,IP 65,II类危险场所,2区,F和G组头和电子只 | |
语言 | 英语,西班牙语,法语,德语,意大利语,荷兰语,汉语,俄语,捷克语,波兰语 | |
供气 | 5.5巴(80 psi)的名义,至少4巴(60磅) | |
产品速度 | 1.7至3300英尺/分钟(0.5〜1000米/分) | |
符合CE认证 | 是 | |
制造商数量 | RX10050 | |
牌 | Thermo Scientific |
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