Page 1 b i o l i n e BioCompact II INSTRUCTIONS FOR USE MODELS: 210/310/410/610 Original Instructions for use Original instructions for use Item No. 765042589 Revision No. 20230623 English...
Page 2: Quick Guide - Biocompact Ii
Quick guide – BioCompact II Parameter settings Temperature settings Standby Defrosting Standby indicator Alarms A2, A3, A4, A5 Key pad lock is activated Standby Press the button to turn the cabinet on. Press the button for 6 seconds to turn the cabinet off. The software version of the cabinet will be shown when turning the cabinet on, followed by the software variant.
Page 3 b i o l i n e Example: Setting the upper limits for the alarms; LhL Press and hold until the display shows LAL Press to select LAL, LhL is now shown in the display Press to select LhL, 25 is shown in the display Press to set the desired value for the upper temperature limit Press...
Page 5: Before You Proceed
If the instructions for use is lost, please refer to your local distributor or Gram Scientific for a replacement.
Page 6: Cabinet Components
BioCompact II 210, 310, 410, 210/210, 310/210 This part describes the main components pertinent to the user. ATTENTION – In the event of technical difficulties or breakdown, always contact Gram BioLine technical support or a Gram BioLine authorized service partner.
Page 7 14 . Digital display for controller Use the display to show the cabinet temperature and, to set the parameters described in this manual. ATTENTION – If parts show signs of damage; do not use cabinet and contact Gram BioLine or supplier for further aid.
Page 8: Biocompact Ii 610
BioCompact II 610 This part describes the main components pertinent to the user. ATTENTION – In the event of technical difficulties or breakdown, always contact Gram BioLine technical support or a Gram BioLine authorized service partner.
Page 9 13 . Digital display for controller Use the display to show the cabinet temperature and, to set the parameters described in this manual. ATTENTION – If parts show signs of damage; do not use cabinet and contact Gram BioLine or supplier for further aid.
Page 10: Installation
Installation Initial setup steps I-1*: Due to safety and operating considerations, the cabinet must not be used outdoors. I-2*: The cabinet should be installed in a dry and sufficiently ventilated area. I-3*: To ensure efficient operation, the cabinet should not be installed in direct sunlight or close to heat sources. The cabinet interior must not be exposed to corrosive atmospheres.
Page 11 b i o l i n e b i o l i n e I-4*: Ambient operating temperature range Minimum ambient Maximum ambient Cabinet operating temperature operating temperature BioCompact II 210, 310, 410, 210/210, 310/210 RR with solid door +10 ºC +35 °C RR with glass door +10 °C...
Page 12 I-9*: Cabinets equipped with legs should be levelled as shown in the illustration below. I-10-11*: For cabinets equipped with castors, the floor must be level to ensure stable positioning and safe use. When the cabinet is positioned, the 2 front castors should be locked. *): Paragraph designation (I-1, I-2 etc) refers to the IQ (Installation Qualification)
Page 13 Reveral of door Item numbers for door hinges For replacement brackets, please contact your local Gram BioLine distributor...
Page 14 The cabinet must not be connected to a power source changing door hinging .
Page 15 b i o l i n e...
Page 16: Anti Tilt Bracket
Anti tilt bracket I-12*: Cabinets with drawers and/or glass door must be secured to a stable vertical surface, ensuring that the cabinet can not tip over when the drawers are drawn to the outermost position, or the door is open. Brackets for securing is included.
Page 17: Wall Mounting
b i o l i n e Wall mounting Find instructions on wall mounting of a BioCompact II 210 below, the same procedure applies for mounting 310, 210/210, 310/210 and 410.
Page 18: Surroundings
Surroundings I-13-14*: The cabinet must be installed in accordance with the illustrations below. 15-75 mm ≥ 15 mm ≥ 30 mm *): Paragraph designation (I-1, I-2 etc) refers to the IQ (Installation Qualification)
Page 19 b i o l i n e I-15*: Do not cover the upper part of the cabinet. I-16*: Do not use electrical appliances inside the cabinet. The cabinet is not suited for storing items that emit vapours, as this might lead to deterioration of cabinet performance and/or longevity.
Page 20: Voltage Free Contact
Voltage free contact I-17*: The illustration shows the three connectors for the relay (used ex. in connecting to CTS or other external monitoring systems). The three connections, are respectively. Common, NO and NC. The moment when voltage is applied the controller draws the relay, this makes it possible for the controller to respond to both high and low alarms, door alarms and power failures.
Page 21 b i o l i n e Placement of voltage free contact BioCompact II 610 BioCompact II 210, 310, 210/210, 310/210, 410 ly Open (NO) Common Common Common ly Open (NC) Common Normally closed circuit (NC) Common Common...
Page 22: Connection To Power
Never use the cabinet if the plug is damaged. The cabinet should be examined by a Gram BioLine service technician in I-19*: The cabinet is intended for connection to alternating such cases.
Page 23 b i o l i n e BioCompact II 610 BioCompact II 210, 310, 210/210, 310/210, 410...
Page 24: Equipotential Bonding
Equipotential bonding Exclusively for the models – BioCompact II 210, 310, 410, 210/210, 310/210 I-22-1*: For installation in ATEX Cat. 3 Zone 2 areas, it is mandatory to have a equipotential bonding, it is not sufficient to use protective earth through the mains connection. To secure equipotential bonding of the unit –...
Page 25 b i o l i n e...
Page 27: Start-Up
Start-up b i o l i n e The digital display Parameter settings Standby indicator Temperature settings Standby Defrosting Alarms A2, A3, A4, A5 Key pad lock is activated O-1*: Standby • Parameter setting Gives access to the cabinets configurable parameters, such as Press to turn the cabinet on.
Page 28: Walkthrough Of Menu
Walkthrough of menu Menu Access Local alarm settings [° C] Upper alarm limit. Code for activated alarm [A2] [° C] Lower alarm limit. Code for activated alarm [A3] [Min.] Delay of upper alarm limit [Min.] Delay of lower alarm limit On/off Door alarm.
Page 29: Error Codes
Error codes b i o l i n e Display code Explanation - 0 - Door is open Door alarm “dAd” from LAL and/or EAL has been activated Local upper alarm LhL is or has been activated Local lower alarm LLL is or has been activated External upper alarm EhL is or has been activated External lower alarm ELL is or has been activated Error on the main cabinet sensor.
Page 30: Local Alarm Settings
Local alarm settings Local high alarm Local low alarm O-3*: LhL – Setting the upper alarm limit [° C] Press and hold for more than 3 seconds Press to select “LAL”. “LhL” is now shown in the display Press to select “LhL”. The upper alarm limit is now shown in the display Press to set the desired value for the upper alarm limit Press...
Page 31: Local Alarm Settings
b i o l i n e b i o l i n e Local alarm settings O-5*: Lhd – Setting the delay of the local upper alarm limit [min.] Press and hold for more than 3 seconds Press to select “LAL”. “LhL” is now shown in the display Press several times until “Lhd”...
Page 32: On/Off Local Door Alarm
On/off local door alarm Delay for local door alarm O-7*: dA – Activate/deactivate of local door alarm Press and hold for more than 3 seconds Press to select “LAL”. “LhL” is now shown in the display Press several times until “dA” is shown in the display Press to select “dA”.
Page 33: Local Acoustic Settings
b i o l i n e b i o l i n e Local acoustic settings O-9*: BU – Activation/deactivation of the acoustic local alarms Press and hold for more than 3 seconds Press to select “LAL”. “LhL” is now shown in the display Press several times until “BU”...
Page 34: External Alarm Settings
External alarm settings External high alarm External low alarm O-10*: EhL – Setting the external upper alarm limit [° C] Press and hold for more than 3 seconds Press several times until “EAL” is shown in the display Press to select “EAL”. “EhL” is now shown in the display Press to select “EhL”.
Page 35: External High Alarm Delay
b i o l i n e b i o l i n e External high alarm delay External low alarm delay O-12*: EHd – Setting the delay of the external upper alarm limit [min.] Press and hold for more than 3 seconds Press to proceed to “EAL”...
Page 36: On/Off External Door
On/off external door External door alarm delay alarm O-14*: dA – Activation/deactivation of external door alarm Press and hold for more than 3 seconds Press to proceed to “EAL” Press to select “EAL”. “EhL” is now shown in the display Press several times until “dA”...
Page 37: External Acoustic Settings
b i o l i n e External acoustic settings O-16*: BU – Activation/deactivation of the acoustic external alarms Press and hold for more than 3 seconds Press to proceed to “EAL” Press to select “EAL”. “EhL” is now shown in the display Press several times until “BU”...
Page 38: Parameter Settings
Parameter settings Sensor offset The temperature sensors connected to MPC controller can be offset independently of each other in the parameter cAL. Offset is used in cases where there are deviations in the cabinets actual operation compared to the display and/or control measurements by independent temperature monitoring.
Page 39 b i o l i n e Offset of the A-sensor Press and hold for more than 3 seconds Press several times until “cAL” is shown in the display Press to select “cAL”. “cA” is shown in the display Press to select “cA”...
Page 40: Escorted/Set Alarm Limits
Escorted/set alarm limits ALL – Setting of escorted/set alarm limits Press and hold for more than 3 seconds Press several times until “ALL” is shown in the display Press to select “ALL” Press to select set or escorted alarm limits Press to confirm the set value Leave the user menu by pressing...
Page 41: Defrosts/24 Hours
b i o l i n e Defrosts/24 hours O-17*: dEF – Number of defrosts Press and hold for more than 3 seconds Press several times until “dEF” is shown in the display Press to select “dEF” Press to set the desired amount of defrosts per 24 hours (factory setting is 4) Press to confirm the set value Leave the user menu by pressing...
Page 42: Display Sensor
Display sensor O-18*: dPS – Display sensor Press and hold for more than 3 seconds Press several times until “dPS” is shown in the display Press to select “dPS” Press to select either the A- or E-sensor Press to confirm the set value Leave the user menu by pressing several times until the cabinet temperature is shown in the display Please note: that dPS only changes the reference sensor for the display, and not the reference sensor for the alarms.
Page 43: Electric Low Temperature Protection
b i o l i n e Electric low temperature protection FP – Activation/deactivation of low temperature protection Press and hold for more than 3 seconds Press several times until “FP” is shown in the display Press to select “FP”. “Act” is now shown in the display Press to select “Act”...
Page 44: Ordinary Use
Ordinary use Keep the marked areas in the cabinet (shown on next page) clear of all items, thereby ensuring adequate air circulation, and therein cooling. Do not place items beneath the lowest shelf bracket. All items in the cabinet that are not encapsulated, or wrapped, should be covered to reduce the risk of corrosion of the cabinet and its components.
Page 45 b i o l i n e BioCompact II 410 BioCompact II 610...
Page 46: Regular Maintenance
Regular maintenance Cleaning The cabinet must not be connected to a power source while cleaning. The cabinet should be cleaned internally with a mild soap solution (max. 85 °C) at suitable intervals and checked thoroughly before it is put into operation again. The compressor compartment and in particular the condenser must be kept free from dust and dirt.
Page 47: Door Gasket
It is therefore very important to be aware of the door gaskets condition. Regular inspection is recommended. The door gasket should be cleaned regularly with a mild soap solution. If a gasket is to be replaced, please contact your local Gram BioLine distributor.
Page 48: General Info
Defective parts must be replaced with original parts from Gram BioLine. Gram BioLine can only guarantee functional and safety requirements on the cabinets, if above mentioned is adhered to.
Page 49: Type/Number Plate
b i o l i n e Type/number plate If refrigeration fails, first look to see whether the cabinet has been unintentionally switched off, or whether a fuse has blown. If the cause of failure cannot be found, contact your supplier quoting Type and S/N. This information can be found on the type/number plate.
Page 50: Defrost Water
Defrost water The cabinet creates defrost water, that is directed out into a re-evaporation tray at the back of the cabinet. BioCompact II 610 Defrost water is led through a tube in the insulation to a re-evaporation tray at the back of the cabinet. BioCompact II 210, 310, 210/210, 310/210, and 410 Defrost water is led through a tube in the insulation to a re-evaporation tray in the compressor room in the cabinet.
Page 51: Access Port
b i o l i n e Access port All BioCompact ll cabinets are equipped with an access port on the back of the cabinets, this can be used to easily fit external sensors. All access ports are constructed in the same fashion, with a conical polystyrene plug (fitted from the back of the cabinet) and a plastic cap (fitted from the inside of the cabinet).
Page 52: Important
Important IMPORTANT! There may be sharp edges on the cabinet housing, compressor room, and interior, show due diligence when handling the cabinet, neglect of these precautions can lead to injuries. Danger of wedging of body parts in the frame slot between the door and the cabinet, show due diligence when opening and closing the cabinet door.
Page 53: Disposal
Disposal b i o l i n e Electrical and electronic equipment (EEE) contains materials, components and substances that can be dangerous and harmful to human health and the environment if the waste (WEEE) is not disposed of properly. Contact you local BioLine distributor when the cabinet needs to be disposed of. Products that are labelled with a “crossed-out wheelie bin ‘is electric and electronic equipment.
Page 54: Datasheet
BioCompact II 210, 310, 410, 210/210, 310/210 Technical specifications Data Connection 230 VAC, 50 Hz Control Unit Gram Control Unit with voltage free contact, alarms and offset function Alarms Acoustic and visual, High/Low temperature alarms and door alarm Alarm ports Voltage free contact Access port 1 pcs.
Page 55: Biocompact Ii 210, 310, 410, 210/210, 310/210
b i o l i n e BioCompact II RR210H BioCompact II RR210H BioCompact II RR210H Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant...
Page 56: Biocompact Ii Rr310H
BioCompact II RR310H BioCompact II RR310H BioCompact II RR310H Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant K-Value 0.35 W/(m2*K) K-Value...
Page 57: Biocompact Ii Rr410H
b i o l i n e BioCompact II RR410H BioCompact II RR410H BioCompact II RR410H Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant...
Page 58: Biocompact Ii Rf210H
BioCompact II RF210H BioCompact II RF310H BioCompact II RF210H BioCompact II RF310H Solid door Solid door Technical specifications Data Technical specifications Data Temperature range -25/-5 °C Temperature range -25/-5 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+35 °C Software variant Software variant K-Value...
Page 59: Biocompact Ii Rf410H
b i o l i n e BioCompact II RF410H BioCompact II RF410H Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+35 °C Software variant K-Value 0.35 W/(m2*K) ATEX marking II 3G Ex ec nC ic llB T3 Gc ATEX certificate DTI 22ATEX0251X Gross volume...
Page 60: Biocompact Ii Rr210/Rr210H
BioCompact II RR210/RR210H BioCompact II RR210/RR210H BioCompact II RR210/RR210H Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant K-Value 0.35 W/(m2*K);...
Page 61: Biocompact Ii Rr210/Rf210H
b i o l i n e BioCompact II RR210/RF210H BioCompact II RR210/RF210H BioCompact II RR210/RF210H Solid door Glass door (RR) Technical specifications Data Technical specifications Data Temperature range +2/+20 °C and -25/-5 °C Temperature range +2/+20 °C and -25/-5 °C Ambient temperature range +10/+35 °C Ambient temperature range...
Page 62: Biocompact Ii Rf210/Rf210H
BioCompact II RF210/RF210H BioCompact II RF210/RF210H Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+35 °C Software variant K-Value 0.35 W/(m2*K) ATEX marking II 3G Ex ec nC ic llB T3 Gc ATEX certificate DTI 22ATEX0251X Gross volume 2 x 125 litres Net volume...
Page 63: Biocompact Ii Rr310/Rf210H
b i o l i n e BioCompact II RR310/RF210H BioCompact II RR310/RF210H BioCompact II RR310/RF210H Solid door Glass door (RR) Technical specifications Data Technical specifications Data Temperature range +2/+20 °C and -25/-5 °C Temperature range +2/+20 °C and -25/-5 °C Ambient temperature range +10/+35 °C Ambient temperature range...
Page 64: Biocompact Ii Rr210G
BioCompact II RR210G BioCompact II RR210G BioCompact II RR210G Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant K-Value 0.35 W/(m2*K) K-Value...
Page 65: Biocompact Ii Rr310G
b i o l i n e BioCompact II RR310G BioCompact II RR310G BioCompact II RR310G Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/35 °C Ambient temperature range +10/+32 °C Software variant Software variant...
Page 66: Biocompact Ii Rr410G
BioCompact II RR410G BioCompact II RR410G BioCompact II RR410G Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant Software variant K-Value 0.35 W/(m2*K) K-Value...
Page 67: Biocompact Ii Rf210G
b i o l i n e b i o l i n e BioCompact II RF210G BioCompact II RF310G BioCompact II RF210G BioCompact II RF310G Solid door Solid door Technical specifications Data Technical specifications Data Temperature range -25/-5 °C Temperature range -25/-5 °C Ambient temperature range...
Page 68: Biocompact Ii Rf410G
BioCompact II RF410G BioCompact II RF410G Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+35 °C Software variant K-Value 0.35 W/(m2*K) ATEX marking II 3G Ex ec nC ic llB T3 Gc ATEX certificate DTI 22ATEX0251X Gross volume 346 litres Net volume...
Page 69: Biocompact Ii Rr210/Rr210G
b i o l i n e BioCompact II RR210/RR210G BioCompact II RR210/RR210G BioCompact II RR210/RR210G Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant K82/K82...
Page 70: Biocompact Ii Rr210/Rf210G
BioCompact II RR210/RF210G BioCompact II RR210/RF210G BioCompact II RR210/RF210G Solid door Glass door (RR) Technical specifications Data Technical specifications Data Temperature range +2/+20 °C and -25/-5 °C Temperature range +2/+20 °C and -25/-5 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant K82/F52...
Page 71: Biocompact Ii Rf210/Rf210G
b i o l i n e BioCompact II RF210/RF210G BioCompact II RF210/RF210G Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+35 °C Software variant K-Value 0.35 W/(m2*K) ATEX marking II 3G Ex nA nC nL llB T3 Gc ATEX certificate DTI 22ATEX0251X Gross volume...
Page 72: Biocompact Ii Rr310/Rf210G
BioCompact II RR310/RF210G BioCompact II RR310/RF210G BioCompact II RR310/RF210G Solid door Glass door (RR) Technical specifications Data Technical specifications Data Temperature range +2/+20 °C and -25/-5 °C Temperature range +2/+20 °C and -25/-5 °C Ambient temperature range +10/+35 °C Ambient temperature range +10/+32 °C Software variant K82/F52...
Page 73 b i o l i n e...
Page 74: Biocompact Ii Rr610H
BioCompact II 610 Technical specifications Data Connection 230 VAC, 50 Hz Control Unit Gram Control Unit with voltage free contact, alarms and offset function Alarms Acoustic and visual, High/Low temperature alarms and door alarm Alarm ports Voltage free contact Access port 1 pcs.
Page 75: Biocompact Ii Rf610H
b i o l i n e BioCompact II RF610H BioCompact II RR610H BioCompact II RR610H Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+43 °C Ambient temperature range +10/+38 °C Software variant Software variant...
Page 76 BioCompact II RF610H Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+43 °C Software variant K-Value 0.31 W/(m2*K) ATEX marking II 3G Ex nA nC nL llB T2 Gc ATEX certificate – Gross volume 583 litres Net volume 419 litres Dimensions –...
Page 77: Biocompact Ii Rr610G
b i o l i n e BioCompact II RR610G BioCompact II RR610G BioCompact II RR610G Solid door Glass door Technical specifications Data Technical specifications Data Temperature range +2/+20 °C Temperature range +2/+20 °C Ambient temperature range +10/+43 °C Ambient temperature range +10/+38 °C Software variant Software variant...
Page 78: Biocompact Ii Rf610G
BioCompact II RF610G BioCompact II RF610G Solid door Technical specifications Data Temperature range -25/-5 °C Ambient temperature range +10/+43 °C Software variant K-Value 0.31 W/(m2*K) ATEX marking II 3G Ex nA nC nL llB T2 Gc ATEX certificate – Gross volume 583 litres Net volume 419 litres...
Page 79 b i o l i n e b i o l i n e...
Page 80: Declaration Of Conformity
Declaration of conformity BioCompact II 210, 310, 410, 210/210 & 310/210 English EC Declaration of Conformity We, Gram Scientific ApS declare under sole responsibility that the following products: Range: BioCompact II Model: 210, 310, 410, 210/210 & 310/210 Refrigeration: R600a & R134a...
Page 81: Biocompact Ii 610
BioCompact II 610 English EC Declaration of Conformity We, Gram Scientific ApS declare under sole responsibility that the following products: Range: BioCompact II Model: Refrigeration: R600a, R290, R404A & R134a Product description: Refrigerators and freezer for laboratory and biostorage...
Page 82: Biocompact Ii 210, 310, 410, 210/210 & 310/210 - Accessories Code 69
BioCompact II 210, 310, 410, 210/210 & 310/210 – Accessories code 69 English EC Declaration of Conformity We, Gram Scientific ApS declare under sole responsibility that the following products: Range: BioCompact II (Accessorie code 69) Model: 210, 310, 410, 210/210 & 310/210 Refrigeration: R600a &...
Page 83: Biocompact Ii 610 - Accessories Code 69
BioCompact II 610 – Accessories code 69 English EC Declaration of Conformity We, Gram Scientific ApS declare under sole responsibility that the following products: Range: BioCompact II (Accessorie code 69) Model: Refrigeration: R600a, R290, R404A & R134a...
Page 84: Wiring Diagram
Wiring diagram BioCompact II 210/310/410...
Page 85: Biocompact Ii 210/310/410 - With Ltp
b i o l i n e BioCompact II 210/310/410 – with LTP...
Page 86: Biocompact Ii Rr610 - With Solid Door
BioCompact II RR610 – with solid door...
Page 87: Biocompact Ii Rf610
b i o l i n e BioCompact II RF610...
Page 88: Biocompact Ii Rr610 - With Glass Door
BioCompact II RR610 – with glass door...
Page 89: Biocompact Ii Rr610 - With Solid Door, With Ltp
b i o l i n e BioCompact II RR610 – with solid door, with LTP...
Page 90: Biocompact Ii Rr610 - With Glass Door, With Ltp
BioCompact II RR610 – med glasdörr, med LTP BioCompact II RR610 – with glass door, with LTP...
Page 91: Piping Diagram
6500 Vojens All rights to this drawing belongs to Gram Scientiﬁc ApS, cf. law of copyright. Thus the drawing should not without our written permission be copied, presented or passed over to a third person. Misuse will lead to prosecution.
Page 92: Iq & Oq
IQ / OQ Organisation: procedures can vary depending on application and items stored in the Gram BioLine cabinet. Deviations from the specifications dictated in the PQ are to be Location of installation: reported in the deviation report.
Page 93 b i o l i n e Instructions on use to starting the cabinet: 1. Training of the responsible party Date: 2. Operational test of the cabinet Date: 3. Responsible party Tel: Instructions to users: The responsible party is trained in use of the cabinet in reference to the user manual General use of cabinet Objections to the mentioned: Service &...
Page 94 Installation Qualification – IQ Comply Description of installation Reference Attachment Notes in manual Ensure the cabinet is installed in- page 10 doors. Ensure the cabinet is installed in a page 10 dry and sufficiently ventilated area. Ensure the cabinet is not in direct contact with sunlight or other heat page 10 sources.
Page 95 b i o l i n e Installation Qualification – IQ Comply Description of installation Reference Attachment Notes in manual Ensure that the inner doors can I-18 operate in accordance with the instructions. Ensure the correct electrical I-19 connection (compare local values page 22 with type/nr plate) Ensure that the power cord is secured...
Page 96 Operation Qualification – OQ Comply Description of operation Reference Attachment Notes in manual Turn on the cabinet – Display test page 27 (software version and variant). Set/adjust set-point temperature. page 27 Set/adjust LhL – page 30 Upper alarm limit (local). Set/adjust LLL –...
Page 97 b i o l i n e Deviation Report: Deviations to the criteria of acceptance are to be documented in the deviation report. A separate deviation report shall be made for each deviation. Mark the entry with the relevant “-ID” specified in the left column in the test specifications.
Page 98 Approval of test results – Installation Qualification (IQ) The steps in the Installation Qualification – IQ were completed with positive results The steps in the Installation Qualification – IQ were completed with negative results ID of steps with negative results: Approval of test results –...
Page 99 b i o l i n e NOTES:...
Page 100: Performance Qualification
Performance Qualification Organisation: Location of installation: Model: ________________________ SN: ________________________ Item number: ________________________ (manual) The PQ consists of inspections of the correct operation of the cabinet Person responsible for the cabinet: under predefined conditions and Name: ________________________________________________ procedures. Date: ________________________________________________ Signature: ________________________________________________ Prerequisites for the PQ are IQ (Installation Qualification) and OQ...
Page 101 b i o l i n e List of names – Persons involved in the test procedure and subsequent report Date Name Organisation Signature Model: ________________________ SN: ________________________...
Page 102 Deviations from the specifications dictated in the PQ, are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement – Prerequisites Description Accepted The cabinet must be empty while conducting tests, ie without interior fittings such as drawers, shelves etc.
Page 103 b i o l i n e Deviations from the specifications dictated in the PQ, are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement –...
Page 104 Deviations from the specifications dictated in the PQ are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement – Temperature stabilization Description Accepted The test is intended to provide substantiation for the temperature stability inside the cabinet during normal operation.
Page 105 b i o l i n e Deviations from the specifications dictated in the PQ are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement –...
Page 106 Deviations from the specifications dictated in the PQ, are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement – Pull-down Description Accepted P-11 The test is intended to provide substantiation for the time it takes for the inside of the cabinet to reach the setpoint temperature specified in P-5.
Page 107 b i o l i n e Deviations from the specifications dictated in the PQ, are to be reported in the deviation report. The PQ is concluded if all criteria of acceptance are approved and the possible deviations are rectified or accepted. Measurement –...
Page 108 Deviation Report Deviations to the criteria of acceptance are to be documented in the deviation report. A separate deviation report shall be made for each deviation. Mark the entry with the relevant “P-ID” specified in the left column in the test specifications. P-ID: Description of deviation: Extent to which the deviation has been alleviated:...
Page 109 b i o l i n e Approval of test results – Performance Qualification (PQ) The steps in the Performance Qualification – PQ were completed with positive results The steps in the Performance Qualification – PQ were completed with negative results ID of steps with negative results: Additional notes: Organisation / Responsible party:...
Page 110 NOTES: Model: ________________________ SN: ________________________...
Page 111 b i o l i n e Appendix BioCompact II Tolerances Door Permissable Pull- Permissable Hold-over Hold- Permissable opening deviation down deviation range* over deviation recovery (minutes) time (minutes) REFRIGERATORS (RR) 210 (Solid door) 35 % 210 (Glass door) 10 % 310 (Solid door) 35 % 310 (Glass door)
Page 112 Gram Scientific ApS Aage Grams Vej 1 · 6500 Vojens · Danmark Tel: +45 73 20 13 00 e-mail: info@gram-bioline.com www.gram-bioline.com...

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