ceia Ths/ph21 series - PRECISION€¦ · w w w.ceia.net ceia Ths/ph21 series VEry hIgh PErformAnCE PhArmACEutICAl mEtAl DEtECtIon SyStEmS phone +39 0575 4181 fax +39 0575 418296 [email protected]

w w w . c e i a . n e t

ceia Ths/ph21 seriesVEry hIgh PErformAnCE PhArmACEutICAl mEtAl DEtECtIon SyStEmS

phone +39 0575 4181 fax +39 0575 418296 [email protected]

� very high throughput rate

� superior Detection capability

� maximum configurability

� fDa Title 21cfr part 11 compliant

�Data Security �Data Integrity �Data Traceability

� Design and construction compliant with 21 cfr parts 210 and 211

w w w . c e i a . n e tCEIA reserves the right to make changes, at any moment and without notice, to the models (including programming), their accessories and options, to the prices and conditions of sale

Best metal Detection solution for compliance with fDa Title 21cfr110 requirementsCEIA thS/PH21 metal Detection Systems offer detection, construction quality and

reliability characteristics that make them the most suitable and effective solution to

automatic elimination of metal contaminants

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 contami-nated product and to check that it has in fact been eliminated.

The data relating to each detection and ejection are stored in an events memory and certify production quality, the inspec-tion itself and programming operations, as well as the periodic functional test phases using standard test samples.

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 firmware. User access is only possible via specific login with User Name and Password, under the control of the System Administrator, who programmes the user profile and associ-ates with each user the functions available to him/her.

The requirements regarding security, integrity and Traceability are therefore satisfied.

new global auto-learn system provides simultaneous maximum sensitivity to all metals starting from a single learning transit

The Ths/ph21 series employs an exclusive autolearn sys-tem for pharmaceutical products which allows optimization of the detection sensitivity to all metals with the maximum speed and precision, equivalent to hundreds of conventional learning transits: results in levels of precision and efficiency never before obtained.

continuous embedded self-calibration control for maximum repeatability and performance consistency over time and with environmental changes

By means of specific signals sent to the transmission and re-ception chain of the Metal Detector, constant monitoring of the detection characteristics is carried out, with consequent constant compensation for any variations caused by environ-mental factors. The result is system stability and constancy in detection performance and product effect neutralization.

pharmaceuTical meTal DeTecTion sysTemsceia Ths/ph21 series

continuous auto-Test function ensuring maximum production safety

special electronic stimuli are sent to the transmission and reception chain of the Ths/ph21 metal Detector series, caus-ing variations in the detection signals which provide checks on detection characteristics. These variations are compared with the reference values stored in the factory at the time of the cal-ibration test. This produces an automatic certified check of the system’s sensitivity; any deviations from permitted tolerances are followed by a signal and the recording of the anomaly.

quality control Test samples

CEIA offers samples for quality test certified in composition, size and electromagnetic response.

� industrial rate design

� rapid data entry with extended keyboard

� easy to read, high-contrast graphic display

� rugged, antivandalic stainless steel keyboard

The THS/PH21 Metal Detector Series keeps the full compatibility with pro-gramming and parameter selection procedures already implemented in ear-lier versions of the THS/PH21. In addition, there is a new organic graphic dis-play with extremely high contrast (3000:1) and a viewing angle up to 180°, and an extended alphanumeric keypad for quick keystrokes.

� quick access functionA new function, simply activated by pressing a dedicated key, allows the most frequently-used functions to be directly recalled. These functions are pro-grammable by the operator, and maintain the access protection criteria ac-cording to FDA Title 21 Part 11 requirements.

� large product memory: 500+ entries with easy alphabetical sorting and pattern matching

A capacious incorporated memory allows over 500 products to be stored, each identifiable by a specific alphanumeric string. The products are automatically listed in alphabetical order, and searches are facilitated by the progressive rec-ognition of the characters selected on the keypad.

modern, rugged and user friendly interface

automatic measurement of the installation quality and environmental compatibility

THS/PH21 Series introduces new tools for the installation and maintenance technicians which allow them to measure the environmental compatibility of the Metal Detector.

These are functions which would otherwise have required the intervention of external instrumentation, now implement-ed in the microcomputer control of the device itself.

The measurements include general mechanical and elec-tromagnetic environmental compatibility.



LACE – ELECTROMAGNETIC COMPATIBILITY LABORATORY

Zona Industriale Viciomaggio 52040 AREZZO – ITALY

Tel. 0575 4181 - Fax. 0575 418290 - EMail:[email protected]

Web site: www.emc-lace.com

COMPETENT BODY FOR ELECTROMAGNETIC COMPATIBILITY

Recognised with Ministerial Decree of the Ministry of Telecommunications - November, 11 - 1998

HIGH QUALIFIED EXTERNAL LABORATORY

Recognised by the Ministry of University and Scientific Research

According to the Law n. 46/1982 and to the Ministerial Decree - December, 15 - 1994

Certificate of Calibration

Description: Reference Sample for Metal Detectors

Shape: SphereDiameter: 3.0 mm

Composition: AISI 316 (non magnetic)

Serial Number: 20316006654

Certificate Nr.: C/20316006654

We certify that the above mentioned Reference Sample has been tested and

its Electromagnetic Specifications (conductivity and permeability) at the

measured frequency corresponds to the LACE reference sample S/N

20216005848. The procedure followed for the sample verification is in

accordance with the LACE procedure IO-EMC EMC-003 and ISO 9001

Standard, so as to grant its traceability.

Our Quality System is certified compliant with ISO 9001 Standard

(CSQ nr: 9115.CEI3).

Temperature 23±5°C Humidity 60±10%

LACE Labs. Person in charge

In

g. E. Sorini

Calibration Date: 2011-03-07 __________________

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Bluetooth connectivity

In the THS/PH21 Series, local connection to the maintenance technician’s computer no longer requires physical access to the interior of the detector or the use of unwieldy connec-tion cables. Instead, the connection is made directly via a Bluetooth device incorporated into the control power Box module, without physical contact, with a consequent sav-ing of time and greater safety for technical and operational personnel. The Bluetooth connection can be used for pro-gramming, monitoring of the signals via the CEIA MD-Scope program and the transfer of the data contained in the Metal Detector’s events memory.

sophisticated network communication capabilities

Ths/ph21 metal Detectors series offer a wide range of in-terface capabilities: the standard version includes two asyn-chronous RS-232 serial connections, which can be used to integrate with the host system or process controllers, and a Bluetooth interface. A series of optional modules for connec-tion to industrial busses or Ethernet networks are also avail-able on request.

� monolithic aisi 316l stainless steel Body

� extremely quick response time providing

full safety in the ejection of contaminated

product

� advanced mechanical and electronic

solutions guarantee the integrity of the

inspected product

� Double confirmation system carefully

monitoring and controlling the complete

opening and closing of the ejection flap

� easy assembly and disassembly of the

parts in contact with product: no tools

required

� Tri-clamp® conforming to iso Dn50

available as an option

* Tri-Clamp® is a trademark registered by Alfa Laval Inc

ejection system specifications


proDucTion line #1

proDucTion line #2

proDucTion line #n

ease of mainTenancemAIntEnAnCE IS rAPID AnD DoES not rEquIrE thE uSE of toolS to ASSEmblE AnD DISASSEmblE thE ComPonEntS

Tri-clamp® conforming To iso Dn50


Ths/ph21npharmaceutical metal detection system for quality control

� ultra high sensitivity to all metals

� Enhanced product throughput rate

� validation solutions available:

�Calibration Standards �Validation Manuals�Compliance Tools �Comprehensive Service & Support�On-line production data validation

� aisi 316l stainless steel construction

� Control Power Box available according to ul 508a

and csa-c22.2 no. 14-05

� 500 product data memories, selectable by local programming or network software

� 10.000 storable events

� High-definition graphic display

� Local programming: 16 keys, 3 with double function

� quick access key for fast programming of user parameters

� aTeX 22 version (available on demand)

Ths/ph21epharmaceutical metal detection system for quality control

� high sensitivity to all metals





� Control Power Box available according to ul 508a

and csa-c22.2 no. 14-05



� 4 X 20 character alphanumeric display



ceia Ths/ph21 metal Detection systems feature extremely high detection sensitivity towards contaminating metals, whether ferrous, non-ferrous or stainless steel, even when these are present in very small quantities

Dw

DH

Dimensions


Ths/ph21 series models Dw DhThs/ph21n & Ths/ph21e 90 x 25 mm 90 25Ths/ph21n & Ths/ph21e 100 x 40 mm 100 40Ths/ph21n-wip & Ths/ph21e-wip 90 x 25 mm 90 25Ths/ph21n-wip & Ths/ph21e-wip 100 x 40 mm 100 40Ths/ph21n-DT & Ths/ph21e-DT 90 x 25 mm 90 25Ths/ph21n-DT & Ths/ph21e-DT 100 x 40 mm 100 40

Ths/ph21n-wip & Ths/ph21e-wipwash-in-place PhArmACEutICAl mEtAl DEtECtIon SyStEm

� Transit tunnel and ejection system completely sealed

� fitted with nozzles for washing water injection and decontamination

� easy integration with tablet press and deduster from the leading manufacturers

Ths/ph21n-DT & Ths/ph21e-DTdust tiGht PhArmACEutICAl mEtAl DEtECtIon SyStEm

� Transit tunnel and ejection system completely sealed

� easy integration with tablet press and deduster from the leading manufacturers

� rapid maintenance, does not require the employment of tools to assemble and disassemble the components

a special BuilT-in washing sysTem allows compleTe cleaning of The conDuiTs afTer compleTion of each proDucTion BaTch

DusT TighT TransiT pipe anD ejecTion

sysTem To prevenT Dispersion of The

proDucT

A

B


Dimensions

The ejecTion sysTem is fiTTeD wiTh an

innovaTive DeflecTor ThaT feaTures

quick response, precise ejecTion of

The conTaminaTeD proDucT anD high

proDucTion flow raTe

Ths/ph21-ffv series models a BThs/ph21n-ffv 100 x 40 mm 90 30Ths/ph21e-ffv 100 x 40 mm 90 30

Ths/ph21n-ffvPhArmACEutICAl mEtAl DEtECtIon SyStEm for Granular and powder products

� ultra high sensitivity to all metals





� Control Power Box available according

to ul 508a and csa-c22.2 no. 14-05



� high-definition graphic display


� quick access key for fast programming of user parameters


Ths/ph21e-ffvpharmaceuTical meTal DeTecTion sysTem for Granular and powder products

� high sensitivity to all metals



�Calibration Standards �Validation Manuals

�Compliance Tools �Comprehensive Service & Support

�On-line production data validation






� 4 X 20 character alphanumeric display



Zona Ind.le 54/G, 52041 Viciomaggio - Arezzo (ITALY)Phone: +39 0575 4181 Fax: +39 0575 418296E-mail: [email protected]

Dp002k0002v3000uk-48233

Ths/mB21modular Conveyor belt systems for THS 21 MeTal DeTecTorS

� very high sensitivity to all magnetic and non-magnetic metals, including stainless steel

� integrated controls for line speed and rejection

� Full compliance with fDa and gmp criteria

� high immunity to environmental interference

� automatic learning & tracking of product effect

� Easy to maintain and inspect

� Digitally adjustable belt speed



Dimensions

Ths/mB21 moDular conveyor BelTs saTisfy The mosT sTringenT requiremenTs of funcTionaliTy, compacT consTrucTion, accuracy anD reliaBiliTy of response in Dealing wiTh conTaminaTeD proDucTs

conveyor belt dimensions (lxWxH) 1800 mm x 85 mm x 875 mm

1800 mm x 150 mm x 875 mm

type of standfeet

castors

flap reject

ejection confirmation/bin full kit

insufficient air pressure control kit

side panels for product containment

test due signalling device (blue)

STaNDarD acceSSorIeS / oPTIoNalS

h

l

wthe table gives the standard dimensions, which are recommended for their competitiveness and rapid availability for shipment. other sizes can be manufactured on request following verification of feasibility by our technical Sales Department.

Basic configuraTionoptical signalling device acoustic signalling device

belt stop in case of alarm synchronization photocell

variable speed complete reversibility of the accessory assembly and of the Metal Detector


Documents

ceia Ths/ph21 series - PRECISION€¦ · w w w.ceia.net ceia Ths/ph21 series VEry hIgh PErformAnCE PhArmACEutICAl mEtAl DEtECtIon SyStEmS phone +39 0575 4181 fax +39 0575 418296 [email protected]