Pharmaceutical Metal Detection System for Quality Control THS PH21

PHARMACEUTICAL METAL DETECTION SYSTEMS

CEIA THS/PH21 Metal Detection Systems oﬀ er detection, construction quality and reliability characteristics that make them the most suitable and eﬀective solution to automatic elimination of metal contaminants.

Validation Solutions Available: Calibration Standards ∫ Validation Manuals ∫ Comprehensive Service & Support ∫ Compliance Tools ∫ On-line Production Data Validation

FDA 21 PART 11 COMPLIANT

The THS/PH21 Metal Detector Series is a high-sensitivity, high-precision measuring instrument. The response from the device is used to directly command ejection of the contaminated product and to verify that it has in fact been eliminated. FDA Code Title 21 Part 11 prescribes rigorous criteria for access to programming and computer data protection, which have been fully adopted in the CEIA THS/PH21 Series ﬁ rm- ware. User access is only possible via a User Name and Password login under the control of the System Administrator, who programs and manages individual user proﬁ les and user functions. As a result, the requirements for security, integrity and traceability are satisﬁ ed. All events performed by the THS/PH21 Metal Detector are recorded in a data log to comply with FDA Part 11 protocol and assist in root cause analysis. The events include detection, ejection, program operations, passwords and periodic functional test phases using standard test samples.

Superior and Consistent Detection
Enhanced Product Throughput Rate
Preventive Maintenance Not Required
Maximum Configurability / Integration
FDA 21 CFR Part 11 Compliant: Data Security; Data Integrity; Data Traceability
Design and Construction compliant with GMP criteria
AISI 316L stainless steel construction
Ultra high sensitivity to all magnetic and non-magnetic metals, including stainless steel
Control Power Box available according to UL 508A and CSA-C22.2 No. 14-05
500 product profiles, selectable by local programming or network software (250 product profiles THS/PH21E)
10,000 storable events (1,000 storable events THS/PH21E)
High-contrast graphic display
Local programming: 16 stainless steel keys, 3 with double function (4 stainless steel keys, 3 with double function THS/PH21E)
Quick Access key for fast programming of user parameters
Antistatic, Jamming Sensor and Bin full Kits (available on demand)

Packaging Solution

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