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

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

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