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12 

1.

 

Based on the volume, calculate the amount of paraformaldehyde and ammonium bicarbonate 
needed as follows: 

o

 

Paraformaldehyde amount (gram): Total volume (m3) x 11gram/m3 

o

 

Ammonium bicarbonate amount (gram): 
Steps to determine the amount of Ammonium Bicarbonate required: 

a.

 

Determine the stoichiometric amount of ammonium bicarbonate needed to produce the 
requisite amount of ammonia gas that would neutralize the resulting formaldehyde gas. 

b.

 

To ensure completion of the reaction, make sure that the weight of ammonium bicarbonate 
is 10% greater than the weight of the paraformaldehyde used. 

2.

 

Typically, formaldehyde is non-penetrative. So the Unit does not have to be pressure tight. 
Completely seal the Unit and ensure air-tightness inside the enclosure by using tapes at all 
appropriate places. Pay special attention to the power supply cables. 

3.

 

Wear appropriate protective clothing. 

4.

 

Spread the paraformaldehyde evenly over the surface of the heating device. Set the thermostat to 
232°C to 246°C (450°F to 475°F). 

5.

 

Another heating device is placed on the work tray for the ammonium bicarbonate. At this stage, the 
ammonium bicarbonate should be restricted from mixing with the air in the Unit. 
 

Following are two ways of restricting Ammonium Bicarbonate: 

Method 1: 

1.

 

Spread the ammonium bicarbonate evenly over the surface of the heating device and then cover the 
device with aluminum foil in such a way that ammonium bicarbonate cannot react with formaldehyde 
while decontamination is in progress. 

2.

 

The aluminum foil can be placed in such a way that it allows ammonia gas to escape when the device 
is heated. Alternatively, some provision can be made for removing the aluminum foil remotely at the 
beginning of the neutralization phase. 

3.

 

Make sure that the deployment of such a removal mechanism doesn’t lead to unsafe levels of 
formaldehyde escaping out of the decontamination bag enclosing the Unit. 

 
Method 2: 

Seal the Unit using a special plastic sheet that has a pair of gloves built into it. The ammonium bicarbonate is 
placed in a sealed container inside the Unit. 
 
Using the built-in gloves, the person performing the decontamination would be able to reach the work zone of 
the Unit without having to break the seal. At the beginning of the neutralization phase, ammonium 
bicarbonate is removed from the sealed container and spread evenly over the surface of the heating device. 
The heating device is then switched on so that ammonia is generated from ammonium bicarbonate. 
 

1.

 

After approximately 25, 50, 75, and 100% of the formalin being evaporated, turn on the Unit blower 
for 10 to 15 seconds to circulate the formalin throughout the unit. 

2.

 

In cases where Unit blower is inoperative, circulation of air inside the Unit should be promoted with 
additional blower or fans, or the time of decontamination should be extended beyond the times 
suggested below. 

3.

 

Allow the formalin vapor a minimum 6 hours (10 to 12 hours is preferable) contact time inside the 
unit. 

4.

 

Once the formalin decontamination time is reached, start the apparatus containing 25% ammonium 
bicarbonate to neutralize the paraformaldehyde. It is recommended to circulate the ammonia by 
turning on the Unit blower at the same interval as the formalin vaporization. Without any circulation, 
the neutralization time should be extended to a minimum of 6 hours. 

5.

 

Let the ammonia vapor to have a contact time of at least 1 hour (2 hours is preferable) after the 
solution has been completely evaporated, before opening the seals. Please be aware that the 
formaldehyde and/or ammonia concentration inside the decontamination bag may be above the STEL 
and full face mask with formalin filter is required when opening the decontamination bag. 

Summary of Contents for FV-001

Page 1: ... Hatboro PA 19040 USA Toll Free USA and Canada 1 877 479 3726 Tel 215 441 9661 Fax 215 441 9660 us escoglobal com usa escoglobal com Esco Micro Pte Ltd 21 Changi South Street 1 Singapore 486 777 Tel 65 6542 0833 Fax 65 6542 6920 www escoglobal com mail escoglobal com ...

Page 2: ... of such change Sentinel are registered trademarks of Esco Material in this manual is provided for informational purposes only The contents and the product described in this manual including any appendix addendum attachment or inclusion are subject to change without notice Esco makes no representations or warranties as to the accuracy of the information contained in this manual In no event shall E...

Page 3: ...Options 4 2 2 1 Before Decontamination Process Start 5 2 2 2 After Decontamination Process Start 7 Chapter 3 Decontamination Process 7 3 1 Formalin Paraformaldehyde Decontamination 8 3 2 Common Equipment Used in Decontamination 8 3 2 1 Common Equipment 8 3 2 2 Appropriate PPE 8 3 2 3 Common Apparatus 8 3 3 Preparation Steps 9 3 4 Recommended Decontamination Sealing Method 9 3 4 1 For Unit without ...

Page 4: ...ii ...

Page 5: ...t Consumables such as filters HEPA ULPA carbon pre filters and fluorescent UV bulbs Esco is not liable for any damage incurred on the objects used on or stored in Esco equipment If the objects are highly valuable user is advised to have in place independent external preventive measures such as connection to a centralized alarm system Factory installed customer specified equipment or accessories ar...

Page 6: ...6 years for Ascent Max Cleanroom Equipment 1 year limited Laboratory Ovens and Incubators 1 year limited CO2 Incubators 2 years limited Containment Pharma Products 2 years limited Ultralow Temperature Freezer 3 years limited 60 months on Compressor The warranty period starts two months from the date your equipment is shipped from Esco facility for international distributors This allows shipping ti...

Page 7: ...y this manual the protection provided by this equipment may be impaired 3 Limitation of Liability The disposal and or emission of substances used in connection with this equipment may be governed by various local regulations Familiarization and compliance with any such regulations are the sole responsibility of the users Esco s liability is limited with respect to user compliance with such regulat...

Page 8: ...vi ...

Page 9: ...ve and its amending directives 92 31 EEC The Electromagnetic Compatibility Directive and its amending directives has been designed to comply with the requirement of the following Harmonized Standard Low Voltage EN 61010 1 2010 EMC EN 61326 1 2006 Class B More information may be obtained from Esco s authorized distributors located within the European Union A list of these parties and their contact ...

Page 10: ...viii ...

Page 11: ...on as all of the formalin ammonia solution has boiled making the unit safer especially in overnight operations It has a maximum capacity of 800 ml for each formalin and ammonia solution and may be used for biohazard safety cabinet decontamination 1 2 Labels Model The model of the unit Serial The serial number of the unit Power The power consumption and electrical requirement of the unit Manufactur...

Page 12: ...2 1 3 Quick View 1 Esco Sentinel Microprocessor Control System 2 On Off switch 3 Formalin Tank Caps 4 Ammonia Tank Caps 5 Stainless Steel Grip Handle 1 2 3 4 5 ...

Page 13: ... the next step or sequence inside one of the menu options 3 Menu Button o To enter and exit from the menu options o To go back to the previous level of the menu options 2 2 Menu Options MENU SET TIME SET ADMIN PIN PRE PROC TIME CONTACT TIME NEUTRAL TIME START PROCESS RESET DEFAULT RESUME STEP SKIP STEP CANCEL STEP HH MM XXXX HH MM HH MM MM This part of the menu tree is only accessible after the de...

Page 14: ...es however the operator can set the time between 01 and 59 minutes MENU PRE PROC TIME MM PRE PROC TIME SET 2 2 1 4 Contact Time Contact time is the formalin residence time or the time between the formalin vaporizing step ends until the ammonia vaporizing step starts During the formalin vaporizing period 25 50 75 and 100 vaporized it is a good idea to turn on the unit biological safety cabinet etc ...

Page 15: ...s 2 2 2 1 Resume Step This menu allows you to resume the decontamination process after a pause i e by accessing menu If there s a power failure during the decontamination process the formalin vaporizer will automatically resume the decontamination process once the power is recovered In this case the operator doesn t even need to access this menu RESUME STEP MENU CONFIRM 2 2 2 2 Skip Step This allo...

Page 16: ...6 ...

Page 17: ...nal Safety and Health Administration USA formaldehyde Short Term Exposure Level STEL is 2 ppm for 15 minutes exposure 4 times a day minimum of 60 minutes in between exposures Any additional local safety regulations should also be observed Personnel should be given adequate training The following links provide general guidelines on formaldehyde safety Regulations Standards 29 CFR Formaldehyde 1910 ...

Page 18: ...er each time after using it 3 2 3 Common Apparatus Beaker Measuring cylinder Tape Decontamination bag Measuring tape Biohazard waste bag 3 3 Preparation Steps 1 It is recommended that a safety briefing be conducted for all personnel in the laboratory where the unit has been placed before carrying out the procedure 2 Access to the laboratory should be restricted during the procedure especially when...

Page 19: ...nts to prevent leakage Overlap the tape at the joints These 2 cables for BSC and for vaporizer should be combined so that only 1 cable should come out from the decontamination bag to minimize chance of formalin leakage To seal the cable first make an Ω shape aluminum tape around the cable and make a 5 cm flat portion going to both directions Then paste the aluminum tape to the floor Put the bottom...

Page 20: ...l steps namely Close the air tight damper Wrap the bag around the ducting system and seal it using aluminum tape Use multiple layer of aluminum tape to make sure that it is sealed correctly Create a rounded shape using aluminum tape so the adhesive part is on the outside Use it to put the bag together Seal the connection with multiple layers of aluminum tape to ensure its leaktightness The BSC is ...

Page 21: ...each for every 1 cubic meter volume to be decontaminated Water is poured into the formalin tank to increase the decontamination area humidity to be above 60 If the room humidity already exceeds 60 and the formalin tank usage needs to be optimized to decontaminate a large space such as a small room then there is no need to add water Please note that the water shall not be poured into the ammonia ta...

Page 22: ...e that the deployment of such a removal mechanism doesn t lead to unsafe levels of formaldehyde escaping out of the decontamination bag enclosing the Unit Method 2 Seal the Unit using a special plastic sheet that has a pair of gloves built into it The ammonium bicarbonate is placed in a sealed container inside the Unit Using the built in gloves the person performing the decontamination would be ab...

Page 23: ...uipped with a formaldehyde canister should be worn The filter for the mask must be selected for the appropriate level of formaldehyde exposure It must also be replaced regularly following the manufacturer s instruction 3 7 Decontamination Validation Procedure optional Place some Bacillus subtilis var niger spore strips inside the Unit prior to decontamination o Work surface table tray o Drain pan ...

Page 24: ...14 ...

Page 25: ...APPENDIX ...

Page 26: ......

Page 27: ...n problems encountered etc 2 Any decontamination procedure performed by either the user or the technician should be recorded down as well 3 Please also record any major maintenance procedure performed by the service technician for example parts replacement recertification etc Date Event User Signature Supervisor Signature In case of emergencies please call Name ____________________________________...

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