2023 Latest Pharmaceutical Factory Isolated Washer Equipment

• Customization: Available
• After-sales Service: 24monthes
• Warranty: 2years
• Model NO.: BW50
• Customized: Customized
• Material: Metal
• Feature: Degradable
• Application: School, Hospital, Lab, Medical Factory
• Condition: New
• Certification: ISO9001, CE
• Draining Way: Exhaust
• Fuel Type: Electric
• Operation Mode: Full-Automatic Control
• Capacity: 30-50kg
• Transport Package: Wooden Case
• Specification: IS09001&CE
• Trademark: sunflower
• Origin: China
• HS Code: 84512900
• Production Capacity: 50sets /Month
• Package Size: 1500.00cm * 1640.00cm * 1880.00cm
• Package Gross Weight: 2000.000kg

Product Description

2023 Latest Pharmaceutical Factory Isolated  Washer Equipment

Model	BW50
Maximum  Capacity kg	50
Inner Drum D×L  mm	φ970×720
Motor Power   kw	5.5
Washing Speed  rpm	35
Rotation  rpm	70
Extracting Rotation rpm	370
Fast Speed Rotation rpm	750
Steam Inlet  mm	DN20
Water Inlet  mm	DN40
Drain  mm	Φ89
Water Pressure  Mpa	0.2-0.3
Steam Pressure  Mpa	0.4-0.6
Air compressor Mpa	0.4-0.5
Water Consumption  kg	700
Steam Consumption  kg	45
Electricity Heating Power Kw	36
Overall Dimension (Front Back) mm	1500 (1550)
Overall Dimension (Left Right) mm	1640 (1720)
Overall Dimension (Height) mm	1880 (2030)
Weight kg	2000
Power Supply V/Pn/Hz	380/3/50

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Barrier Washing Extractor machines are widely used in laundry shops, hospitals and pharmaceutical factories.This machine has Two way opening, separate opening for dirty and clean side of washing machine ,The dirty clothes will be put into the washer extractor at one side of the barrier washer extractor and the washed and disinfectant clothes will be unloaded from the clean room to avoid cross infection.

1.1  Additional Features

• All metallic non cloth contact surfaces should be constructed of stainless steel AISI 304 / 1.4301 or higher quality with external surface finish < 1.2 µm Ra, matt finish
• Internal finish of drum: polished (vendor to submit details)
• Sealing material and non-metal parts for elements having contact with product: Food Grade with FDA certificate 
• Vendor to ensure all pipe connections are as per latest ASME BPE / ISPE standards
• T/C nozzles and sanitary fittings

 

• External doors with verticals hinges and easy to handle, reversible
• Automatic drum positioning and locking for the loading and unloading operation
• Large door opening for easy loading and unloading
• Energy saving design
• Power balance that ensures the best extraction whatever the loading condition are
• Constant airflow over time for a process always under control
• 4 compartment soap box to use liquid or powder and detergents
• Static prevention system
• Control-panel, showing all the process relevant parameters
• Control panel will be featured with the following:
  • Programming buttons
  • Optical interface for PC
  • Multi-function selector with turn and press mechanism
  • Cycle complete lamp for status indication
  • Wash cycle running LAMP for status indication
  • Emergency Stop Switch
• Integrated weighing system to optimise the loading operations
• Water inlet valve shall be provided
• All conditions of important actuators, drives, operational situations, safety equipment and similar items, must be monitored

1.2    Safety Features 

• Emergency stop function on accessible areas
• Appropriate closure on all rotating parts
• Appropriate failure detection and alarm notification
• On power failure equipment must come to rest to protect operator and equipment itself and the cloth must remain protected from any kind of product quality degradation
• Power restart must not be automatic and human intervention must be required
• The electrical system of the equipment shall be housed as per the cGMP and cGEP
• Machine shall consist of emergency button and control ON/OFF switch

1.3  Material of Construction

• All metallic non cloth contact surfaces should be constructed of stainless steel AISI 304 / 1.4301 or higher quality with external surface finish < 1.2 µm Ra, matt finish
• Internal finish of drum: polished (vendor to submit details)
• Sealing material and non-metal parts for elements having contact with product: Food Grade with FDA certificate 
• Vendor to ensure all pipe connections are as per latest ASME BPE / ISPE standards
• T/C nozzles and sanitary fittings

The complete hardware and software systems shall comply with the current requirements for the use of computerized systems in the pharmaceutical industry, especially the requirements of

1.4  General Conditions

• Annex 11: computerized systems (revision January 2011), EC guide to good manufacturing practice for pharmaceutical products (EC-GMP Guideline- cGMP)
• GAMP 5
• FDA 21 CFR Part 11 (Validated Software)

1.5  Access Regulations / User Administration

• User-administration (i.e. password issue) is to be carried out by the IT- administrator
• Access to the equipment controls shall be restricted by means of password
• Ethernet / Modem for the remote access for the service

1.6  System Reliability and Measures

The system is designed according to the environmental conditions and process requirements so that, even under full-load and continual-operation, the required performance capability is always guaranteed. Should there be a system breakdown, the re-establishment of the previous state must be possible, if necessary by using the backup copies.

1.7  Quality Control Measures

• For the software development, the contractor must present a quality management with test environment and test tools, which is to be audited
• The standard modules and whichever adaptations are required must be descriptively presented
• For the operation, the system and operator handbooks must be supplied in English including fault correction procedures. Maintenance procedures and intervals must be stipulated. All necessary procedures for data protection / backups, user administration, system recovery and routines for fault analysis / rectification, are to be documented in the manuals
• The source code must be permanently stored by the supplier
• The processing of data (process sequences, algorithms, interlocks, supervision, and alarms, fault processing, logging, plausibility check) shall be undertaken
• Safe, easily directed menu guided interface for the user
• User friendly structured operation of the control interface (clarity, logical format, ergonomic layout), to rule out errors being caused by incorrect operation
• Diagrammatic display of parameter values (trend curve)
• Input and output-data are to be displayed in suitable form, so that the operator can enter data quickly and easily (monitor, keyboard, mouse, or similar)
• An appropriate procedure is to be planned for the storage of process-data, so that the data can be deposited on the operating computers hard-disk, using clear file names

1.8  Data Processing

• The processing of data (process sequences, algorithms, interlocks, supervision, and alarms, fault processing, logging, plausibility check) shall be undertaken
• Safe, easily directed menu guided interface for the user
• User friendly structured operation of the control interface (clarity, logical format, ergonomic layout), to rule out errors being caused by incorrect operation
• Diagrammatic display of parameter values (trend curve)
• Input and output-data are to be displayed in suitable form, so that the operator can enter data quickly and easily (monitor, keyboard, mouse, or similar)
• An appropriate procedure is to be planned for the storage of process-data, so that the data can be deposited on the operating computers hard-disk, using clear file names
• Sensors for process relevant parameters must be calibrated. Suitable adjustment possibilities are to be planned

• Washing cycle report shall be available for print with start /end including stage cycle

1.9  Printouts

• Total cycle time
• Trend curves
• Detergent and softening agent quantity used
• US FDA 21 CFR part 11 compliance printout

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