ZHAFIR MEDICAL PACKAGES
ZHAFIR MEDICAL FOR CLEAN PRODUCTION
The Zhafir electric machines with certified medical packages are designed to meet the industry’s high production standards. The medical version of the Zeres electric with integrated hydraulics and the Venus all-electric brings a whole bundle of turnkey solutions for clean production to the table.
The Zhafir Zeres and Venus meet these cleanroom requirements:
Machine Sizes with Medical Package
VE and ZE400 III to 4500 III (45 US tons to 506 US tons)
Injection shot sizes: 0.38 ounces to 75.56 ounces
Medical Packages available in two levels
HEADQUARTERS:
33 Southgate Street
Worcester, MA 01610
Phone: (508) 459-5372
OHIO TECH CENTER:
Service, Support & Parts
12900 Plaza Drive
Parma, OH 44130
Phone: (216) 452-1000
parts@absolutehaitian.com
service@absolutehaitian.com
ILLINOIS TECH CENTER:
280 Belleview Lane
Batavia, IL 60510
Phone: (630) 761-9898
SOUTH CAROLINA FACILITY:
1328 Garrott Ave.
Moncks Corner, SC 29461
Phone: (843) 420-1919
Locations
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Basic and Advanced medical packages
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Comprehensive hardware allows cleanroom applications for various industries
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Hardware, Software & Documentation for the medical sector approved by PQE Group
Basic Package Hardware Overview
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Anti-static white color
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Feet with smooth surface
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Barrel protective cover without mesh
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Additional machine cover parts
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Special oil plate under moving platen
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Stainless steel hopper slider
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Fuselage beams wrapped in stainless steel with holes (operator and non-operator sides)
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Bottom plate of fuselage in product drop area wrapped in stainless steel
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Water divider wrapped with cover
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Stainless steel hopper
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Fixed platen wrapped in additional sheet metal to prevent accumulation of dust
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Machine base raised about 100 mm
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Inlaid barrel seat with stainless steel to prevent rust and other pollution of raw materials
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Injection screw observation hole
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Closing of holes in order to prevent accumulate dust
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Food grease lubricants
Encapsulated clamping unit
Advanced Package Software Overview
Process Integrity, Traceability and Accountability
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Automatic daily backup of production data
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Audit trail
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Date & time not changeable
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Reports for Alarms, Audit trails & trends:
Print/export data in not modifiable formats -
Non-blocking trend alarms
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Auto Log-Off time for all profiles, unable to configure for single operators
Advanced Package Documentation Overview
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All verification forms incl. date and signatures of the test executor
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Specified calibration’s status lists of instruments:
Operator initials, calibration date, calibration’s next due date, Instrument ID and calibration certificate ID. -
Dedicated test script
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Audit table to track Start of Production (SOP)
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Adequate relative testing procedure, acceptance criteria & data collection table
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Statistical rationale and determination of pieces
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Critical parameters (Design of Experiments)
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Validated methods for measurements
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Test results on components attached to protocol
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All verification forms including date and signatures of the test executor
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Specified calibration’s status lists of instruments:
Operator initials, calibration date, calibration’s next due date, Instrument ID and calibration certificate ID. -
Dedicated test script
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Audit table to track Start of Production (SOP)
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Adequate relative testing procedure, acceptance criteria & data collection table
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Statistical rationale and determination of pieces:
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Critical parameters (DOE)
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Validated methods for measurements
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Test results on components attached to protocol
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These documentation requirements have been approved by PQE Group
Proof of Process Stability
The screen captures below provide an example of the process stability (repeatability and consistency) of a running Zeres III Medical Package machine, showing eight different processing parameters:
Additional options available upon request
Quality flaps and conveyors