Holland Green Science Xiros 2 User manual

User Manual
Version 1.0 1
10407001
Xiros 2 Lyophilizer
User Manual

User Manual
Version 1.0 2
Table of Contents
I. Disclaimer & Warranty .................................................................................................. 4
LIMITED WARRANTY & DISCLAIMER .................................................................................... 4
LIMITATION OF LIABILITY....................................................................................................... 7
II. Safety ............................................................................................................................. 8
III. Xiros 2 Lyophilizer Introduction.................................................................................10
3.1 Purpose......................................................................................................................10
3.2 Hardware Diagram......................................................................................................10
3.3 Hardware....................................................................................................................11
3.4 Software .....................................................................................................................11
3.5 Abbreviations..............................................................................................................11
3.6 After Sales Support ....................................................................................................11
3.7 Proper Use .................................................................................................................12
IV. Technical Specifications..............................................................................................13
V. Inspection ……………………………………………………………………………………...17
5.1 Packing List ................................................................................................................17
VI. Installation...................................................................................................................19
6.1 Safety Rule.................................................................................................................19
6.2 Transportation.............................................................................................................19
6.3 On-Site Assembly.......................................................................................................19
6.4 Tools needed…….……………………………………………………………………………19
6.5 Chamber Set up…………...…………………………………………………………………20
6.5.1 Chamber Location ………………………………………………………………………..21
VII. Components Assembly …………………………………………………….………………..22
7.1 Vacuum System Assembly .........................................................................................22
7.2 Instrumentation Installation.........................................................................................23
7.3 Electric Cabinet Installation.........................................................................................23
7.4 Expansion Tank Installation........................................................................................24
VIII. Oil Refilling ……………………………………………………………………………………26
8.1 Vacuum Pump Oil Level..............................................................................................26
8.2 Refilling the Silicon Oil................................................................................................27
IX. Software Operation …………………………………………………………………………28
9.1 User Permission Management...................................................................................28

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9.2 Software Operating Instructions.................................................................................30
9.3 Recipe........................................................................................................................31
9.4 Recipe Setting Parameters ........................................................................................32
9.5 Recipe Management..................................................................................................34
9.6 Parameter Manager...................................................................................................37
X. Flow Charts of Operations ………………………………………………………………...39
10.1 Operation Sequences.................................................................................................43
10.2 Manual De-icing Operation .........................................................................................45
10.3 Alarm/Safety Message................................................................................................47
10.3.1 Check Alarm Messages.......................................................................................47
10.3.2 Alarm Records.....................................................................................................48
10.3.3 Alarm List.............................................................................................................50
10.3.4 Events List...........................................................................................................52
XI. Final Commission Checks …….…………………………………………………………..53
11.1 Preparation.................................................................................................................53
11.2 Inspection Prior to Operation ......................................................................................53
11.3 Utility Data and Parameters........................................................................................53
XII. Maintenance and Cleaning ………………………………………….…………………….54

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I. Disclaimer & Warranty
•The intellectual property rights for this manual belongs to Holland Green Science
Corporation (hereinafter referred to as “the Company”).
•Products of the company are under the patent protection of China and other countries
and regions (inclusive of obtained patents and patents currently under application).
•The company reserves the right to change product specifications without notice.
•The contents of the manual are subject to change without notice.
•The manual’s content must not be copied, extracted, or modified in any form without the
Company’s permission.
LIMITED WARRANTY & DISCLAIMER
Products sold by the Company are intended solely for the use(s) specified by the manufacturer
and are not to be used for any other purposes including, but not limited to, unauthorized
commercial purposes. Buyer warrants and represents that Buyer will properly test, use, qualify,
and/or validate each Product for intended use, and, to the extent authorized, manufacture and
market any final articles made from the Company’s Products in accordance with the practices of
a reasonable person who is an expert in the field, and in strict compliance with all applicable
national, state and local laws and regulations. Buyer acknowledges and understands that the
purchase of Products only conveys to Buyer the non-transferable right for only the Buyer to use
the Products purchased in compliance with the applicable manufacturer's Published User
Statement, Limited User Statement, or Limited License, if any. While this manual contains
certain representations of the potential dangers from the instrument or equipment, Buyer is
solely responsible for conducting any research necessary to learn the hazards involved for any
of its intended uses of the instrument or equipment purchased from the Company and to
properly warn its customers, employees and other personnel who may be exposed to such
instrument or equipment of any risks involved in using or handling the instrument or equipment.
The Company warrants that this product will operate or perform substantially in conformance
with the Company’s published specifications and be free from defects in material and
workmanship, when subjected to normal, proper and intended storage and usage by properly
trained personnel, for the duration of the manufacturer’s warranty period set forth in this product
documentation, published specifications or package inserts. If a manufacturer’s warranty period
is not specified in the product documentation, published specifications or package inserts, the
warranty period shall be one (1) year from the date of Bill of Sale to Buyer for equipment, and
the earlier of any stated expiration dates or ninety (90) days for all other products (the "Warranty
Period"). The Company agrees during the Warranty Period, to repair or replace, at the
Company’s option, defective Products so as to cause the same to operate in substantial
conformance with said published specifications; provided that Buyer shall (a) promptly notify the

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Company in writing upon the discovery of any defect, which notice shall include the product
model and serial number (if applicable) and details of the warranty claim; and (b) after the
Company's review, the Company will provide Buyer with service data and/or a Return Material
Authorization ("RMA"), which may include biohazard decontamination procedures and other
product-specific handling instructions, then, if applicable, Buyer may return the defective
Products to the Company with all costs prepaid by Buyer. Replacement parts may be new or
refurbished, at the election of the Company. All replaced parts shall become the property of the
Company. Shipment to Buyer of repaired or replacement Products shall be made in accordance
with the Delivery provisions of the Terms & Conditions agreed to by the purchase of this
product. Consumables are expressly excluded from this warranty.
Notwithstanding the foregoing, Products supplied by the Company but not manufactured by the
Company are not warranted by the Company, and the Company disclaims all warranties
associated with the accuracy of any original manufacturer or third-party supplier Product
information, but the Company agrees to assign to Buyer any warranty rights in such Product
that the Company may have from the original manufacturer or third-party supplier, to the extent
such assignment is allowed by such original manufacturer or third-party supplier.
In no event shall the Company have any obligation to make repairs, replacements or corrections
required, in whole or in part, as the result of (i) normal wear and tear, (ii) accident, disaster or
event of force majeure, (iii) misuse, fault or negligence of or by Buyer, (iv) use of the Product in
a manner for which they were not designed, (v) causes external to the Product such as, but not
limited to, power failure or electrical power surges, (vi) improper storage and handling of the
Product or (vii) use of the Product in combination with equipment or software not supplied by the
Company. If the Company determines that Product for which Buyer has requested warranty
services are not covered by the warranty hereunder, Buyer shall pay or reimburse the Company
for all costs of investigating and responding to such request at the Company's then prevailing
time and materials rates. If the Company provides repair services or replacement parts that are
not covered by this warranty, Buyer shall pay the Company therefor at the Company's then
prevailing time and materials rates.
ANY INSTALLATION, MAINTENANCE, REPAIR, SERVICE, RELOCATION OR ALTERATION
TO OR OF, OR OTHER TAMPERING WITH, THE PRODUCT PERFORMED BY ANY
PERSON OR ENTITY OTHER THAN THE COMPANY WITHOUT THE COMPANY'S PRIOR
WRITTEN APPROVAL, OR ANY USE OF REPLACEMENT PARTS NOT SUPPLIED BY THE
COMPANY, SHALL IMMEDIATELY VOID AND CANCEL ALL WARRANTIES WITH RESPECT
TO THE PRODUCT.
THE OBLIGATIONS CREATED BY THIS WARRANTY STATEMENT TO REPAIR OR
REPLACE A DEFECTIVE PRODUCT SHALL BE THE SOLE REMEDY OF BUYER IN THE

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EVENT OF A DEFECTIVE PRODUCT. EXCEPT AS EXPRESSLY PROVIDED IN THIS
WARRANTY STATEMENT, THE COMPANY DISCLAIMS ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO THE
PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR USE. THE
COMPANY DOES NOT WARRANT THAT THE PRODUCTS ARE ERROR-FREE OR WILL
ACCOMPLISH ANY PARTICULAR RESULT.
NOTHING IN THIS MANUAL OR IN THE TERMS AND AGREEMENT AGREED TO AT THE
TIME OF PURCHASE SHALL BE CONSTRUED TO PROVIDE FOR THE TRANSFER,
ASSIGNMENT OR ALIENATION OF THE LIMITED WARRANTIES PROVIDED BY THE
COMPANY HEREIN TO ANY OTHER PARTY OTHER THAN BUYER, INCLUDING BUT NOT
LIMITED TO, SUCCESSORS, HEIRS, SUBSIDIARIES OR ANY OTHER THIRD PERSON.
THE WARRANTIES IDENTIFIED ABOVE ARE THE SOLE AND EXCLUSIVE WARRANTIES
WITH RESPECT TO THIS PRODUCT AND ARE IN LIEU OF ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED. ALL OTHER WARRANTIES ARE EXPRESSLY DISCLAIMED,
INCLUDING, WITHOUT LIMITATION, THOSE OF NON-INFRINGEMENT,
MERCHANTABILITY, OR FITNESS FOR A SPECIFIC PURPOSE OR USE (WHETHER
ARISING FROM STATUTE, OR OTHERWISE IN LAW, OR FROM A COURSE OF DEALING,
OR USAGE OF TRADE). THIS WARRANTY IS NOT TRANSFERABLE FROM THE ORIGINAL
PURCHASER TO A SUBSEQUENT OWNER. FURTHER, THE COMPANY IS NOT LIABLE IN
CASES OF DELIBERATE, NEGLIGENT OR ACCIDENTAL MISUSE OF THE PRODUCTS,
USE WITH INAPPROPRIATE REAGENTS OR CONSUMABLES, DAMAGE CAUSED BY
DISASTER, REPAIR OR MODIFICATIONS DONE BY ANYONE OTHER THAN THE
COMPANY. THE COMPANY DOES NOT WARRANT THAT THE PRODUCT WILL NOT
INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY EITHER ALONE
OR IN COMBINATION WITH OTHER PRODUCTS OR IN THE OPERATION OF ANY
PROCESS. THE COMPANY’S TOTAL LIABILITY FOR BREACH OF THESE WARRANTIES
SHALL BE LIMITED TO THE GROSS PURCHASE PRICE FOR THE PRODUCT AS STATED
IN THE RELEVANT INVOICE OR ORDER UNDER WHICH THE ACTIVITY GIVING RISE TO
LIABILITY ARISES. UNDER NO CIRCUMSTANCES SHALL THE COMPANY BE LIABLE FOR
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES
(INCLUDING LOSS OF BUSINESS OR PROFITS) UNDER ANY THEORY OF LIABILITY
HEREUNDER.
For claims under the warranty please contact your local supplier. You may also send the
instrument directly to manufacturer, enclosing the invoice copy and by giving reasons for the
claim.

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LIMITATION OF LIABILITY
NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, THE
LIABILITY OF THE COMPANY UNDER THESE TERMS AND CONDITIONS (WHETHER BY
REASON OF BREACH OF CONTRACT, TORT, INDEMNIFICATION, OR OTHERWISE, BUT
EXCLUDING LIABILITY OF THE COMPANY FOR BREACH OF WARRANTY (THE SOLE
REMEDY FOR WHICH SHALL BE AS PROVIDED UNDER THIS SECTION) SHALL NOT
EXCEED AN AMOUNT EQUAL TO THE LESSER OF (A) THE TOTAL PURCHASE PRICE
THERETOFORE PAID BY BUYER TO THE COMPANY WITH RESPECT TO THE
PRODUCT(S) GIVING RISE TO SUCH LIABILITY OR (B) ONE HUNDRED THOUSAND
DOLLARS ($100,000), WHICHEVER IS LESS.
With respect to any software products incorporated in or forming a part of the Product
hereunder Buyer intends and agrees that such software products are being licensed and not
sold, and that the words "purchase", "sell" or similar or derivative words are understood and
agreed to mean "license", and that the word "Buyer" or similar or derivative words are
understood and agreed to mean "licensee". Notwithstanding anything to the contrary contained
herein, The COMPANY or its licensor, as the case may be, retains all rights and interest in
software products provided hereunder. See the Terms & Conditions of purchase for details
regarding such license.

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II. Safety
IMPORTANT Safety Items to be Observed.
Safety Warnings
The lyophilizer is designed in accordance with industry safety standards.
Incorrect operation may result in safety hazards for personnel and/or the equipment.
! DANGER (May cause serious damage to property and or casualties)
1. Verify that all discharging ports are properly connected.
2. Utility requirements: ensure that the electrical meets the local standard and that the
power supply is compatible to the Instrument nameplate. The power source must be
properly grounded.
3. Avoid touching the pipelines (e.g. compressor exhaust pipes) to prevent scalding from
high temperatures.
4. Avoid touching the chamber’s inside and external surfaces due to high or low
temperatures and to prevent scalding or frostbite.
5. Only trained refrigeration engineers may service the refrigeration system.
6. When conducting maintenance and or operations inside the chamber, ensure the door
is securely held open.
7. Ensure appropriate PPE is worn at all times! Unprotected hands are not to open or
close the door.
8. Note: Persons are not to enter the chamber.
9. It is prohibited to use flammable liquids or gas inside or around the instrument.
The lyophilizer is not designed with explosion prevention.
! WARNING (May cause property damage or personal injury)
1. Do not stand on any instrument piping
2. Prior to operating this instrument, all operators are required to fully read this manual.
Only trained and qualified operators should use the instrument.
3. It is prohibited to install any non-manufacturer authorised software onto this instrument
4. Nitrogen gas is recommended to detect any system leakage and avoid danger.
5. Power ‘OFF’ the power supply for PLC and all electrical equipment before working on
the instrument.
6. Confirm the main power is ‘OFF’ prior to opening the cabinet door.
IMPORTANT:
7. Periodic checks of the heater junction box are required to ensure the terminal screws
do not become loose or the wiring ages.

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8. It is recommended that every five (5) years the electric heater be replaced.
9. It is recommended that once a month a qualified person checks the solid-state relay
to confirm the solid-state relay is running correctly to avoid breakdowns.
Note: The electrical heater will continuously heat in the event the solid-state relay
breaks down, leading to the potential of a serious hazard.
10. Immediately power ‘OFF’ the electrical heater if the electrical heater over temperature
alarm alerts / sounds. If the above is not resolved fully power ‘OFF’ and unplug from the
main power supply and arrange a service technician to investigate and repair.
! ATTENTION (May affect operational performance or service life)
11. The overall safe operation of the instrument is the responsibility of the owner of the
instrument and their assigned operator(s), who in turn are responsible for ensuring the
user manual guidance is applied to, optimise the safety and protection of personnel and
the Instrument before, during and after lyophilizer operation.
12. Timely maintenance of the instrument MUST be maintained to ensure continued safe
operation, good instrument condition thus optimising the instruments service life.
13. Only accredited and qualified professional repair technicians can open the instrument or
conduct required repairs. Persons performing repairs on the instrument other than those
selected or approved by the Company shall operate to void any warranty contained
hereinabove for the product.

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III. Xiros 2 lyophilizer Introduction
3.1 Purpose
This manual provides a basic overview of the Xiros 2 lyophilizer and guide to its
operation. Please read the user manual carefully before using the freeze dryer.
3.2 Hardware Diagram

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3.3 Hardware
All processing automation is controlled by SIEMENS HMI (Human Machine Interface)
6AV2124-0GC01-0AX0 using an 8GB memory card. A screen is used for process
monitoring and control.
3.4 Software
The control and supervision of the lyophilizer is carried out by Portal V15 and the
program monitors.
3.5 Abbreviations
Unit
Meaning
s/sec
second
min
minute
P
pressure
T/h
ton/hour
h
hour
L
litre
3.6 After Sales Support
If you have questions related to the product installation or need technical assistance,
please contact the after-sales service department. The company may provide technical
assistance and information regarding the instrument or equipment or service without
charge at its sole discretion. Buyer assumes sole responsibility for any reliance on or
use of such assistance and information, and the Company makes no warranty thereon.
Upon contact the following information is required to be provided
Product Serial Number (located on rear panel instrument nameplate)
•Warranty card
•Description of issue or problem (i.e., software or hardware)
•Method and or operating steps you have undertaken towards resolution.
•Your contact details inclusive of telephone number and email address.

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For claims under the warranty please contact your local supplier. You may also send the
instrument directly to manufacturer, enclosing the invoice copy and by giving reasons for
the claim.
3.7 Proper Use
The lyophilizer is designed for use in large scale manufacturing and mining operations. It
is ideal for academic and cooperate research laboratories. To prevent damage to the
lyophilizer it should only be used in clean and safe environments free of corrosive gases
and intense magnetic fields.

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IV. Technical Specifications
Model
10407001
Product Name
Xiros 2 lyophilizer
Chamber
A. Design Specifications
SN
Description
Specifications
1
Chamber type
Cylindrical
2
Internal finish
Ra≤0.8µm
B. Technical Configuration
SN
Name
MSM
QTY
1
Chamber internal material
SS 304
N/A
2
External plate
SS 304, thickness 1.5mm
N/A
3
Insulation
Polyethylene material
N/A
4
Temp. sensors of thermal fluid
JUMO, A level Pt-100 hot
resistance
2
Shelf
A. Design Specifications
SN
Description
Specifications
1
Production methods
Plug welding
2
Design pressure
3barg
3
Temperature Range
-35~+25°C
4
Finish
Ra≤0.8µm
5
Level
≤±1mm/m
B. Technical Configuration
SN
Name
MSM
QTY
1
Shelf material
SS 304
N/A
2
Shelf gross dimensions
650×600×12mm
N/A
3
Shelves spacing
51mm
N/A
4
Total net shelf area
2.73m2
N/A
5
Quantity
7+1 (upper radiant shelf)
N/A
6
Trays
Size:295*650*63.5mm
Material: 304 SS
14
Door
A. Design Specifications

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SN
Description
Specifications
1
Main door open direction
According to user’s requirements
2
Main door open angle
110°
3
Internal finish
Ra≤0.8µm
B. Technical Configuration
SN
Name
MSM
QTY
1
Material of main door
SS 304
N/A
2
External cover of door
SS 304
N/A
3
Sight glass without illuminated
DN150
1
Coils
A. Design Specifications
SN
Description
Specifications
1
Maximum ice capacity
10Kg/batch
2
Minimum coiled temp.
-50°C
B. Technical Configuration
SN
Name
MSM
QTY
1
Coils pipe material
SS 304
N/A
2
Temp. sensors of coils
Jumo, A level Pt-100 Hot resistance
1
Refrigeration System
A. Design Specifications
SN
Description
Specifications
1
Shelf cooling speed on empty
load (Silicone oil inlet)
+25~-35°C≤60min.
2
Coils cooling speed on empty
load
+20~-40°C≤30min.
B. Technical Configuration
SN
Name
MSM
QTY
1
Compressor
Copeland
1
2
Refrigerant
CFC-free R448A
TBD
3
Solenoid valve
Danfoss
TBD
4
Expansion valve
Danfoss
TBD
5
Pressure meter
Refco
1
Circulation System

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A. Design Specifications
SN
Description
Specifications
1
Heating rate
Approx 1°C/min（unloaded, from -35℃to +25℃
）
2
Silicon oil viscosity
5cSt@25°C
B. Technical Configuration
SN
Name
MSM
QTY
1
Circulation pump
WILO, Top-SD40/10
1
2
Thermal fluid
Low viscosity silicone oil
TBD
3
Heater
4Kw
1
4
Plate heat exchanger
Alfalaval
1
5
Temp. sensors of thermal fluid
Jumo, A level Pt-100 Hot resistance
2
Vacuum System
A. Design Specifications
SN
Description
Specifications
1
Final vacuum
2.6Pa
2
Evacuation speed
From 1 atm. to 10pa≤30min
3
Leakage rate
5×10-3pa.m3/sec.
B. Technical Configuration
SN
Name
MSM
QTY
1
Vacuum pump
Youcheng,TRP-36
1
2
Valve for condenser isolation
DN50
1
3
Vacuum gauge
Edwards
1
Aeration System
A. Technical Configuration
SN
Name
MSM
QTY
1
Aeration valve
Edwards
1
2
Pipeline
SS304
TBD
Control System
A. Design Specifications
SN
Description
Specifications
1
Electric standard
UL

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2
Protection class
IP22
3
Software function
Freeze drying (manual and automatic).
De-icing (manual)
4
Max recipe number
Six(6)
5
Date
History date, history audit, history alarm can be
stored for a maximum of one month
6
Permissions
3 Level permissions.
(administrator, operator, parameter)
7
User management
B. Technical Configuration
SN
Name
MSM
QTY
1
PLC
Siemens CPU-1200
1
2
Touch screen
Siemens TP700 smart Comfort
1
Utility Requirements (Approx.)
SN
Description
Requirements
1
Total power
19Kw @ 480V, 60Hz, 3P, 5W
2
Clean air for aeration system
40L/min @ 0.5~1bar
3
Room environment temperature
≤25℃
Standard Documentation
SN
Name
QTY
1
Operation Manual (OM)
1
2
Installation Manual (IM)
1
3
Pipes & Instruments Drawing (P&ID)
1
4
Layout Drawing
1
5
Electric Drawing
1

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VInspection
5.1 Packing List
Unpack the equipment carefully and check for any damage which may have arisen during
transport. In the event of identified damage, please contact the supplier / manufacturer for
technical support.
•Carefully unpack the shipping container.
•Remove the Instrument and place it onto a clean, level surface.
•Check the instrument and accessories against the below ‘Packing List’.
If the instrument or accessories are found to be incorrect, or the accessories are incomplete
or abnormal, please contact the supplier/ manufacturer.
No.
Type
Name
Unit
Qty.
Remark
1
Main Unit
Lyophilizer
pcs
1
2
Quick Setup Card
1
3
Spare part
Tray
pcs
14
4
Spare part
Alarm light
pcs
1
5
Spare part
Bellows of vacuum pump
inlet
pcs
1
6
Spare part
Vacuum gauge (EDWARDS)
pcs
1
7
Spare part
Moisture filter DAB-90-90
pcs
1
8
Spare part
Electric ball valve
pcs
1
9
Spare part
Connection
pcs
1
10
Spare part
Move the wheel
pcs
4
11
Spare part
screws
pcs
16
12
Spare part
Elbow
pcs
1
13
Spare part
Sight glass
pcs
1
14
Spare part
Clamp ISO50
pcs
3
15
Spare part
Gasket ISO50
pcs
3
16
Spare part
Clamp ISO38
pcs
5

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No.
Type
Name
Unit
Qty.
Remark
17
Spare part
Gasket ISO38
pcs
5
18
Spare part
Clamp KF40
pcs
2
19
Spare part
Gasket KF40
pcs
2
20
Spare part
Older KF40
pcs
2
21
Spare part
Vacuum pipe
pcs
1
22
Spare part
After pressure pipe
pcs
1
23
Spare part
Uninterruptible power supply
(UPS）
pcs
1
24
Spare part
Silicon oil
L
20
25
Document
File package
box
1
Note:
If you find any visible damage, please do not connect the instrument to
a Power supply.

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VI. Installation
6.1 Safety Rule
Please read the user manual carefully before operating the lyophilizer. Only properly
trained and qualified personnel should operate the lyophilizer.
6.2 Transportation
Before transporting the lyophilizer, drain the silicon oil and refrigerant into separate
containers to avoid leakage during transportation.
6.3 On-Site Assembly
Before assembling the lyophilizer, make sure the area of use meets the following
conditions:
•Remove any caustic, flammable and explosive materials from the workshop area.
The lyophilizer should be located on a level flat surface.
•The lyophilizer should be operated in a temperature controlled environment between
5℃to 30℃.
•The workshop area must be free of excessive vibration for proper operation of the
lyophilizer.
•The lyophilizer should not be directly exposed to sunlight.
6.4 Tools needed
•meter ruler, laser leveler
Fig 1: Meter Ruler.

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6.5 Chamber set up
Benchmark choice of the general chamber
Fig 2: Laser Leveller
Fig 3
The vertical surface of
the box frame is the
vertical reference.