Pall Allegro 50 L, Инструкция по эксплуатации

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1. Introduction
The following instructions are provided for installation of the Pall 50 L Allegro single-use mixer systems in
50 L plastic and jacketed Allegro mixer hardware. The Allegro 50 L mixer can be used for a wide range
of applications required in the production of drug products, such as media and buffer preparation as well
as final formulation preparations. The instructions contained in the product documentation should be
read thoroughly because they contain valuable information gained by extensive experience. It is very
important that all instructions are carefully followed and, where appropriate, they should be incorporated
into the user’s standard operating procedures. If some of the procedures do not suit your needs, please
consult Pall or your local distributor before finalizing your system. Use of this product in a manner other
than in accordance with Pall’s current recommendations may lead to injury or product loss. Pall cannot
accept liability for such injury or loss.
2. Warning
Operation outside the specifications defined in the product data sheet or with fluids incompatible with
materials of construction may cause personal injury and result in damage to the equipment. Incompatible
fluids are fluids that may chemically attack, soften, stress, attack or otherwise adversely affect the
materials of construction. Please refer to Pall for exact limits for contact fluids and conditions.
The use of solutions containing low molecular weight alcohol, especially isopropyl alcohol to decontaminate
the exterior of the biocontainers may, in circumstances where significant stress (repetitive bending and
twisting) is applied during use, cause damage to the molded LDPE inlet and outlet ports. The flexible
LDPE film of the Allegro 3D biocontainers is not affected.
This mixer must only be used by persons who have been trained and authorized to do so.
3. Receipt of Equipment
3.1 Allegro Mixer Hardware
• Take care when removing the supplied mixer hardware from the shipping container. Use
appropriate equipment when removing the mixer hardware from the shipping container
• Locate or store the hardware in an appropriate indoor location. The equipment is designed
for operation in clean rooms and classified areas and as such should be maintained in a
clean state and stored when not in use in an appropriate clean location free from adverse
environmental conditions
• Only use mixer when brakes are engaged on the castors
• Do not attempt to move the mixer during use
• Use on an even surface
• Always position the equipment so that the emergency stop button and mains isolation switch
can be readily accessed
CAUTION!
The User Control Interface (UCI) is configured for correct operation prior to delivery and is there-
fore not required to be opened during normal operation. The UCI must only be opened by a
qualified servicing engineer.
The mixer is earthed through the mains supply cable.
3.2 Single-Use Systems
Store the Allegro 3D single-use mixer system in clean, dry conditions between 2 and 40 °C
without exposure to radiation sources like direct sunlight and, wherever practical, in the
packaging as delivered.
Do not remove from packaging until just before use.
Check that the packaging is undamaged prior to use.
www.pall.com/biopharm 2