Pall Allegro 1000 L Instructions For Use Manual Download Page 3

1.

Introduction

The following procedure is provided for the installation of Pall single-use systems incorporating Allegro 3D
biocontainers with capacities of 1000 L, 2000 L and 3000 L in the corresponding stainless steel Allegro
totes. Pall Allegro 3D biocontainers must be used in accordance of this manual. The instructions contained
in the biocontainer product documentation should be read thoroughly because they contain valuable
information gained by extensive experience. It is very important that all instructions in this document 
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.

Considerations for Care and Use of Allegro Biocontainers

Warning:

Operation outside the parameters defined in the product data sheet or with fluids incompatible

with construction materials may cause personal injury and result in damage to the equipment. Incompatible
fluids are fluids which chemically attack, soften, stress, attack or adversely affect the materials of 
construction. The system should never attempt to be transported or moved when filled. Please refer 
to Pall for exact limits and refer to USTR2527: Allegro 3D biocontainer validation guide. For more 
information please contact [email protected].

Warning:

The use of solutions containing low molecular weight alcohol, especially isopropyl alcohol, to

decontaminate the exterior of the Allegro 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 biocontainers is not affected.

3.

Receipt of Equipment

Allegro 3D biocontainers are usually provided as part of an Allegro system that has been sterilized by
gamma irradiation by request.

1. Store the Allegro 3D biocontainer/system in clean, dry conditions between 0 and 30 °C without 

exposure to radiation sources like direct sunlight and, wherever practical, in the packaging as delivered.

2. Do not remove from packaging until just before use.

3. Check that the packaging is undamaged prior to use.

Caution:

Avoid the use of sharp blades or pointed instruments that could damage the Allegro 3D 

biocontainers and other system components, and potentially damage the filter (if included). Do not open
the bag by forcing any of the system components through the sealed end because this can generate
particulate contaminants.

4. Ensure that the Allegro 3D biocontainer system selected is suitable for the application.

5. In addition to the part number, each biocontainer is identified by a unique lot number.

4.

Installation and Operation

The hardware to support the 1000 L, 2000 L and 3000 L Allegro biocontainer systems are made of 
a stand, a base module that supports the 1000 L biocontainer, and available extension modules to 
accommodate the 2000 L and 3000 L Allegro biocontainer systems respectively, depending on the 
configuration (refer to Figure 1). Both the base module and the extension modules consist of passivated
304 SS. A hoist is necessary extend the top of the Allegro biocontainer for the 2000 L and 3000 L sizes.
It is not needed with the 1000 L base module.

Note:

A crane or fork lift should be onsite to stack the extension modules.

www.pall.com/biopharm

3

Summary of Contents for Allegro 1000 L

Page 1: ...USD 3055 Instructions for Use Allegro 3D Biocontainers and Allegro Totes 1000 L 2000 L and 3000 L ...

Page 2: ...the hoist 7 4 3 Installation of the Allegro biocontainer system 10 4 4 Filling the Allegro biocontainer system 11 4 5 Draining the Allegro biocontainer 13 4 5 1 From the bottom 1000 L 2000 L and 3000 L 13 4 5 2 From the Top 1000 L only 13 4 6 Removing Allegro 3D biocontainer from the Allegro tote 13 5 Allegro Biocontainer Replacement 13 6 Troubleshooting Guide 13 7 Scientific and Laboratory Servic...

Page 3: ...e the exterior of the Allegro 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 biocontainers is not affected 3 Receipt of Equipment Allegro 3D biocontainers are usually provided as part of an Allegro system that has been sterilized by gamma i...

Page 4: ... installation of the Allegro base and extension module To prepare the tote for use 1 Check that the area designated for use is clear and can accommodate the hardware system being installed Ensure that the surface area is flat level and strong enough to bear the weight of the tote when full If required prepare studs for screwing the feet down Please refer to Table 1 for clearance 2 Using a forklift...

Page 5: ... base modules feet are completely aligned with the holes on the stand frame so the bolts can be inserted Figure 4 Figure 4 Stand frame alignment with base module 5 Once the bolts on the base module are aligned with the holes on the stand slowly lower the fork lift to drop the bolts into place Figure 5 Figure 5 Bolts inserted into four holes www pall com biopharm 5 ...

Page 6: ...0 L Attach the two lifting plates to the top of the extension module by dropping one end over a position pin and aligning the other side with a bolt into the hole Fasten down with a washer and nut and the adjustable wrench Figure 7 The lifting plates will be used to lift the extension module Figure 7 Lifting plate secured to top of extension module Attach crane or hoist carabiner to the two lockin...

Page 7: ... bottom washers to secure the base module to the extension module Figure 10 Figure 10 Secure ten bolts with nuts and washers 4 2 Preparation and installation of the hoist 1 Attach the hoist bracket to the top of the extension module by placing each side of the bracket frame holes into the positioning pins Fasten the other hole on the bracket feet using a bolt with nut and washer Figure 11 This is ...

Page 8: ...ning the two flat head screws secure it to the cable This will prevent the cable from disconnecting from the friction wheel Figure 13 Figure 13 Cable fastened by cable lock 4 Using a ladder pull the end of cable that has carabiner through large center pulley on hoist frame directly above extension module 5 Feed cable down from the center pulley until the stainless cable with carabiner attached is ...

Page 9: ...ob on each arm and slide each arm to the four tote corners The cross frame arms should be adjusted so they are 15 20 mm from the tote inner corners Figure 16 Figure 16 Knob turned to extend crossframe arm 8 Using the friction wheel raise the crossbar inside the tote to prepare for biocontainer installation Figure 17 Figure 17 Operator raising crossframe www pall com biopharm 9 ...

Page 10: ... biocontainer system 1 Confirm that the selected Allegro 3D biocontainer system is suited for the tote 2 Inspect the Allegro biocontainer system packaging Verify that it is free from damage that might compromise the integrity of the system 3 Remove the system from its packaging Do not unfold the Allegro biocontainer 4 Hold the Allegro 3D biocontainer with the port plate facing down at the bottom a...

Page 11: ...iner Secure the lower swivel door and replace locking pin Attach the four hoist clips to the holes four holes located at each corner of the top of the biocontainer Ensure each clip fastens to the corresponding hole so that the crossbar is holding the four connection points Figure 22 Figure 22 Four hoist clips connected to biocontainer holes 4 4 Filling the Allegro biocontainer system Once the bioc...

Page 12: ...ons 7 As the filling is in progress the operator MUST regularly raise the hoist to avoid folds developing Warning Failure to raise the hoist during the filling process may result in a fold in the biocontainer that can potentially cause uneven filling Warning Do not open the doors during filling operation Note Allegro 1000 L 3D biocontainers can be filled from either the top or bottom ports The 200...

Page 13: ... towards you 5 Remove the Allegro biocontainer system 5 Allegro Biocontainer Replacement Allegro 3D biocontainers systems are designed for single use and should be replaced in line with the cGMP requirements of the process Discard the Allegro 3D biocontainer system in accordance with local Health and Safety and Environmental procedures 6 Troubleshooting Guide Problem Allegro biocontainer is not fi...

Page 14: ...1 516 484 5400 phone biopharm pall com e mail European Headquarters Fribourg Switzerland 41 0 26 350 53 00 phone LifeSciences EU pall com e mail Asia Pacific Headquarters Singapore 65 6389 6500 phone sgcustomerservice pall com e mail International Offices Pall Corporation has offices and plants throughout the world in locations such as Argentina Australia Austria Belgium Brazil Canada China France...

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