BUCHI B-390 User Manual

Operation Manual
Encapsulator
B-390
115 9347 7 en
Table of contents
Table of contents
1 About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
2.1 User qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 Proper use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Improper use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.4 Safety warnings and safety signals used in this manual . . . . . . . . . . . . . . . . . 7
2.5 Product safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.5.1 General hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.5.2 Safety measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.5.3 Built-in safety elements and measures . . . . . . . . . . . . . . . . . . . . . . . . 10
2.6 General safety rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.7 Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1 Scope of application and delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1.1 Standard instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.1.2 Standard accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.3 Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.4 Recommended spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2 Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3 Materials used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4 Description of function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.1 Functional principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2 Connections at the Encapsulator B-390. . . . . . . . . . . . . . . . . . . . . . . . 18
5 Putting into operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1 Installation site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.2 Installing the Encapsulator B-390 . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.3 Electrical connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.4 Assembling of the bead producing unit . . . . . . . . . . . . . . . . . . . . . . . . 22
5.5 Single (inner) nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.6 Electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.7 Pressure bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.7.1 Installation of the pressure bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.8 Option: Concentric nozzle system . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.8.1 Mounting of CN nozzles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.9 Final installation check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Read this manual carefully before installing and running your system and note the safety precautions in chapter 2 in particular. Store the manual in the immediate vicinity of the instrument, so that it can be consulted at any time. No technical modifications may be made to the instrument without the prior written agreement of BUCHI. Unauthorized modifications may affect the system safety, the EU conformity or result in acci­dents. This manual is copyright. Information from it may not be reproduced, distributed, or used for competi­tive purposes, nor made available to third parties. The manufacture of any component with the aid of this manual without prior written agreement is also prohibited.
The English manual is the original language version and serves as basis for all translations into other languages.
3 B-390 Operation Manual, Version C
Table of contents
6 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.1 Starting up the instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.2 Screens and menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.3 Menu structure of the control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.4 Manual air pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.5 Practicing with the Encapsulator, using water . . . . . . . . . . . . . . . . . . . . . 35
6.6 Practicing with the Encapsulator, using alginate solution. . . . . . . . . . . . . . . . 38
6.6.1 Preparation of 1.5 % Na-alginate solution . . . . . . . . . . . . . . . . . . . . . . . 38
6.6.2 Working with alginate solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.7 Theoretical background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.7.1 Bead productivity and cell density . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7 Maintenance and repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.1 Customer service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.2 Housing condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.3 Sealing conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.4 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.4.1 Cleaning the nozzle after each immobilization run . . . . . . . . . . . . . . . . . . . 47
7.4.2 Cleaning a clogged nozzle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
7.4.3 Cleaning the bead producing unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.1 Malfunctions and their remedy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9 Shutdown, storage, transport and disposal . . . . . . . . . . . . . . . . . . . . . . . . 50
9.1 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.2 Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
10 Declarations and requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
10.1 FCC requirements (for USA and Canada) . . . . . . . . . . . . . . . . . . . . . . . 52
10.2 Health and Safety Clearance form . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
10.3 Declaration of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
4 B-390 Operation Manual, Version C
1 About this manual
This manual describes the Encapsulator B-390. It provides all information required for its safe opera­tion and to maintain it in good working order. It is addressed to laboratory personnel in particular.
If the instrument is used in a manner not specified in this manual, the protection provided by the instrument may be impaired.
Abbreviations
EPDM Ethylene Propylene Dimonomer FEP Fluorelastomer PTFE Polytetrafluoroethylene

1 About this manual

5 B-390 Operation Manual, Version C
2 Safety
This chapter points out the safety concept of the instrument and contains general rules of behavior and warnings from direct and indirect hazards concerning the use of the product. For the user's safety all safety instructions and the safety messages in the individual chapters shall strictly be observed and followed. Therefore, the manual must always be available to all persons performing the tasks described herein.
2.1 User qualification
The instrument may only be used by laboratory personnel and other persons, who on account of training and professional experience know the dangers, which can develop when operating the instru­ment.
Untrained personnel or persons, who are currently being trained, require careful supervision by a quali­fied person. The present Operation Manual serves as a basis for training.

2 Safety

2.2 Proper use

The Encapsulator B-390 has been designed and built as laboratory instrument.
The Encapsulator B-390 is a semi-automated instrument used for the polymer encapsulation of chemical substances, bio-molecules, drugs, flavor & fragrances, pigments, extracts, cells and micro­organisms under open conditions. Aseptic working conditions are possible, because all parts in contact with the encapsulation mixture are autoclavable.
The bead formation is based on the fact that a controlled, laminar liquid jet is broken into equally sized beads, if vibrated at an optimal frequency. The Encapsulator B-390 provides just such controlled conditions to generate beads between 0.15 to 2 mm. The instrument is ideally suited to encapsulate particles < 50 µm.
If the instrument is used with potentially toxic or hazardous substances, it has to be installed inside a closed fume hood or glove box. In such case, the complete processing and system handling has to be performed within the ventilated box to avoid toxication and other hazardous situations to the user
and the environment.

2.3 Improper use

Applications not mentioned in section 2.2 are considered to be improper. Applications which do not comply with the technical data (see section 3 of this manual) are also considered to be improper.
The operator bears the sole risk for any damages or hazards caused by improper use!
The following uses are expressly forbidden:
• Installation or use of the instrument in rooms, which require ex-protected instruments.
6 B-390 Operation Manual, Version C

2.4 Safety warnings and safety signals used in this manual

DANGER, WARNING, CAUTION and NOTICE are standardized signal words for identifying risk levels, related to personal injury and property damage. All signal words, which are related to personal injury are accompanied by the general safety sign.
For your safety it is important to read and fully understand the below table with the different signal words and their definitions!
Sign Signal word Definition Risk level
DANGER
Indicates a hazardous situation which, if not avoided, will result in death or serious injury.
2 Safety
★★★★
WARNING
CAUTION
NOTICE
no
Supplementary safety information symbols may be placed in a rectangular panel on the left to the signal word and the supplementary text (see below example).
Space for
supplementary
safety
information
symbols.
Table of supplementary safety information symbols The below reference list incorporates all safety information symbols used in this manual and their
meaning.
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
Indicates possible property damage, but no practices related to personal injury.
!
SIGNAL WORD
Supplementary text, describing the kind and level of hazard/risk seriousness.
List of measures to avoid the herein described, hazard or hazardous situation.
...
...
(property damage only)
★★★☆
★★☆☆
★☆☆☆
Symbol Meaning
General warning
Electrical hazard
7 B-390 Operation Manual, Version C
Explosive gases, explosive environment
Harmful to live-forms
Device damage
Pressurized gas/air
2 Safety
Hot Surface
Wear laboratory coat
Wear protective goggles
Wear protective gloves
Additional user information Paragraphs starting with NOTE transport helpful information for working with the device/software or its
supplementaries. NOTEs are not related to any kind of hazard or damage (see example below).
NOTE
Useful tips for the easy operation of the instrument/software.
8 B-390 Operation Manual, Version C

2.5 Product safety

Safety warnings in this manual (as described in section 2.4) serve to make the user alert and to avoid hazardous situations emanating from residual dangers by giving appropriate counter measures. However, risks to users, property and the environment can arise when the instrument is damaged, used carelessly or improperly.

2.5.1 General hazards

The following safety messages show hazards of general kind which may occur when handling the instrument. The user shall observe all listed counter measures in order to achieve and maintain the lowest possible level of hazard.
Additional warning messages can be found whenever actions and situations described in this manual are related to situational hazards.
!
Warning
Death or serious injuries by use in explosive environments.
Do not operate the instrument in explosive environments.
Do not operate the instrument with explosive gas mixtures.
Before operation, check all gas connections for correct installation.
Directly withdraw released gases and gaseous substances by sufficient ventilation.
2 Safety
!
Warning
Pressure increase in the inlet-system due to clogged nozzles.
Bursting of the inlet system.
Death or serious poisoning by contact or incorporation of harmful substances at use.
Clean nozzle immediately after use, see section 7.4.
!
Warning
Death or serious injuries by contact with high voltage.
Only open the housing of the product when machine is switched off and unplugged.
Risk of instrument short-circuits and damage by liquids.
Do not spill liquids over the instrument or parts of it.
Wipe off any liquids instantly.
Ensure a safe positioning of the sample vessel.
Do not move the instrument when it is loaded with liquid.
Keep external vibrations away from the instrument.
Notice
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2 Safety
Risk of instrument damage by wrong mains supply.
External mains supply must meet the voltage given on the type plate.
Check for sufficient grounding.
Risk of damaging labratory glasses or utensils by moving syringe pump unit.
Do not place any laboratory glasses or other utensils on the Encapsulator.

2.5.2 Safety measures

Always wear personal protective equipment such as protective eye goggles, protective clothing, and gloves when working with the instrument.

2.5.3 Built-in safety elements and measures

Notice
Notice
High voltage and electrostatic charges
• Safety current limitation.
• Internal grounding to arrest electrostatic charges.
Air/Gas
• Over pressure safety valve (opens at 1.5 bar)
10 B-390 Operation Manual, Version C

2.6 General safety rules

Responsibility of the operator The head of laboratory is responsible for training his personnel.
The operator shall inform the manufacturer without delay of any safety-related incidents which might occur during operation of the instrument. Legal regulations, such as local, state and federal laws applying to the instrument must be strictly followed.
Duty of maintenance and care The operator is responsible for the proper condition of instrument at use and that maintenance,
service and repair jobs are performed with care and on schedule by authorized personnel only.
Spare parts to be used Use only genuine consumables and genuine spare parts for maintenance to assure good system
performance and reliability. Any modifications to the spare parts used are only allowed with the prior written permission of the manufacturer.
Modifications Modifications to the instrument are only permitted after prior consultation with and with the written
approval of the manufacturer. Modifications and upgrades shall only be carried out by an authorized BUCHI technical engineer. The manufacturer will decline any claim resulting from unauthorized modifi­cations.
2 Safety

2.7 Disclaimer

Use and marketing of any material produced with the Encapsulator are in the sole responsibility of the operator.
11 B-390 Operation Manual, Version C
3 Technical data
This chapter introduces the reader to the instrument and its specifications. It contains the scope of delivery, technical data, requirements and performance data.

3.1 Scope of application and delivery

The scope of delivery can only be checked according to the individual delivery note and the listed order numbers.
NOTE
For additional information about the listed products, see www.buchi.com or contact your local dealer.

3.1.1 Standard instrument

3 Technical data

Table 3-1: Standard instrument
Product Order no.
Encapsulator B-390 50 – 60 Hz, 100 – 240 V
Complete Encapsulator B-390 system for microencapsulation under open working conditions with integrated nozzle heating and with liquid pumping by air pressure.
11058210
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3.1.2 Standard accessories

3 Technical data
Table 3-2: Standard accessories
Set of 8 single nozzles 11057918
Set of 8 single nozzles with high precision opening of 0.08, 0.12, 0.15, 0.20, 0.30,
0.45, 0.75 and 1.00 mm, made of stain­less steel 316L including nozzle rack
Pressure bottle 500 mL 11058190
Pressure bottle 1000 mL 11058191
Glass bottles with fittings, tubes and air filter, working pressure up to 1.5 bar, autoclavable

3.1.3 Optional accessories

Grounding set 11058189
Operation Manual English 11593477
Table 3-3: Optional accessories
Product Order no.
Concentric nozzle set 11058051
Set of 7 external nozzles with high preci­sion opening of 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 and 0.9 mm made of stainless steel, incl. 1000 mL pressure bottle
13 B-390 Operation Manual, Version C

3.1.4 Recommended spare parts

3 Technical data
Table 3-4: Recommended spare parts
Product Order no.
O-ring set for single nozzle 11057954
O-ring set for concentric nozzle 11057955
Pre-filters for nozzle, diameter 7 mm (10 pcs.)
Drain filters for reaction vessel, diameter 35 mm (10 pcs.)
11057957
11057958
14 B-390 Operation Manual, Version C

3.2 Technical data

Table 3-5: Technical data Encapsulator B-390
Power consumption max. 150 W
Connection voltage 100–240 VAC
Mains supply voltage fluctuations up to ±10% of the nominal voltage
Frequency 50/60 Hz
Fuse 3.15 A Dimensions (W × H × D) 32×29×34 cm
Weight 7 kg
Nozzle diameter of single (= core) nozzles 0.08, 0.12, 0.15, 0.20, 0.30, 0.45, 0.75 and 1.00 mm
Nozzle diameter of shell nozzles 0.20, 0.30, 0.40, 0.50, 0.60, 0.70 and 0.90 mm
Droplet size range 0.15 to 2.00 mm
Vibration frequency 40 to 6,000 Hz
Electrode tension 250 to 2,500 V
Heating 30 to 70 °C
Pump rate by air pressure 0.5 to 200 mL/min
Maximal allowed air pressure in the system 1.5 bar
Reactor gross volume 4.5 liter
Reactor working volume 2 liter
Parts in contact with medium autoclavable
Sterile working conditions limited
Overvoltage category II
Pollution degree 2
Environmental conditions:
3 Technical data
Temperature 5–40 °C for indoor use only
Altitude up to 2000 m
Max. relative humidity (curve parameter) Maximum relative humidity 80 % up to 31 °C, then
decreasing linearly to 50 % relative humidity at 40 °C
Table 3-6: Material and Approvals
Material in contact with sample stainless steel, silicone, glass, FEP, PTFE
Approvals CE, CSA

3.3 Materials used

Table 3-7: Materials used
Component Material description
Bead producing unit Stainless steel, PTFE, glass fibers
Nozzles Stainless steel, sealings: EPDM
Pressure bottle Stainless steel, 3.3 boroscillate glass, FEP, PTFE
15 B-390 Operation Manual, Version C
sealings: silicone, EPDM
sealings: silicone, EPDM
4 Description of function
This chapter explains the basic working principle of the Encapsulator B-390. It also shows how the instrument is structured and provides a general functional description of its assembly.

4.1 Functional principle

The instrument provides the following key functions:
Reproducible bead size from one production to the next
– Adjustable parameters (nozzle size, liquid flow rate and vibration frequency) determine bead
size.
Reproducible bead formation
– In the range of 0.15 mm to 2.0 mm.

4 Description of function

High bead size uniformity
– Due to the integrated Electrostatic Dispersion Unit (EDU); approximately 5 % relative standard
deviation of bead size using pure alginate.
Immediate process control
– Visual monitoring in the light of a stroboscope lamp.
High cell viability
– Bead formation technique is at low shear stress and under physiological conditions, thus
resulting in high cell survival.
Batch size
– T
he batch size is of 5 mL to 1’000 mL and the dead volume is approximately 2 mL.
Set of 8 single nozzles
– The 8 nozzle sizes of 0.08, 0.12, 0.15, 0.20, 0.30, 0.45, 0.75 and 1.0 mm cover the bead size
range of approximately 0.15 mm to 2.0 mm.
Delivery of the polymere mixture
– By air pressure with flow rates from 70 mL/h (0.08 mm nozzle) to 2’500 mL/h (1.0 mm nozzle).
High bead production
– Up to 6000 beads are produced per second depending on encapsulation conditions and
polymer mixture.
16 B-390 Operation Manual, Version C
4 Description of function
Figure 4-1: Schematic representation of the Encapsulator B-390
a Pressure bottleBead producing unitVibration unitSingle nozzleElectrode Dispersion control
Vibration controlLED/stroboscopePolymerization bathMagnetic stirrer
(P) Air pressure
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