Copyright Information

Transcription

1 Esco Technologies, Inc Turnpike Drive, Units Hatboro, PA 19040, USA Toll-Free USA and Canada Tel Fax us.escoglobal.com User Manual Esco Micro Pte. Ltd. 21 Changi South Street 1 Singapore Tel Fax mail@escoglobal.com

2 Copyright Information Copyright 2011 Esco Micro Pte. Ltd. All rights reserved. The information contained in this manual and the accompanying product is copyrighted and all rights are reserved by Esco. Esco reserves the right to make periodic minor design changes without obligation to notify any person or entity 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 Esco be held liable for any damages, direct or consequential, arising out of or related to the use of this manual.

3 i i iii v v v v v vii Table of Contents Warranty Terms and Conditions Introduction 1. Products Covered 2. Safety Warning 3. Limitation of Liability 4. European Union Directives on WEEE and RoHS Declaration of Conformity INTRODUCTORY PAGES 1 Chapter 1 -Product Information About Esco Formalin Vaporizer Labels Quick View USER SECTION 3 Chapter 2 -Control System Sentinel Control System Menu Options Before Decontamination Process Start After Decontamination Process Start 7 Chapter 3 - Decontamination Process Formalin/Paraformaldehyde Decontamination Common Equipment Used in Decontamination Common Equipment Appropriate PPE Common Apparatus Preparation Steps Recommended Decontamination Sealing Method For Unit without Ducting For Unit with Ducting Decontamination Process Formalin Ammonia Combination Paraformaldehyde Ammonium Bicarbonate Combination Completion Steps Decontamination Validation Procedure (optional) APPENDIX Formalin Vaporizer

4 ii

5 iii Esco products come with either a 1, 2 or 3 year limited warranty, depending on the product purchased, beginning on the date of shipment from any Esco international warehousing location. To determine which warranty applies to your product, refer to the appendix below. Esco's limited warranty covers defects in materials and workmanship. Esco's liability under this limited warranty shall be, at our option, to repair or replace any defective parts of the equipment, provided if proven to the satisfaction of Esco that these parts were defective at the time of being sold, and that all defective parts shall be returned, properly identified with a Return Authorization. This limited warranty covers parts only, and not transportation/insurance charges. This limited warranty does not cover: Freight or installation (inside delivery handling) damage. If your product was damaged in transit, you must file a claim directly with the freight carrier. Products with missing or defaced serial numbers. Products for which Esco has not received payment. Problems that result from: o External causes such as accident, abuse, misuse, problems with electrical power, improper operating environmental conditions. o Servicing not authorized by Esco. o Usage that is not in accordance with product instructions. o Failure to follow the product instructions. o Failure to perform preventive maintenance. o Problems caused by using accessories, parts, or components not supplied by Esco. o Damage by fire, floods, or acts of God. o Customer modifications to the product 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 are warranted only to the extent guaranteed by the original manufacturer. The customer agrees that in relation to these products purchased through Esco, our limited warranty shall not apply and the original manufacturer's warranty shall be the sole warranty in respect of these products. The customer shall utilize that warranty for the support of such products and in any event not look to Esco for such warranty support. Esco encourages all users to register their equipment online at or complete the warranty registration form included with each product. ALL EXPRESS AND IMPLIED WARRANTIES FOR THE PRODUCT, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED IN TIME TO THE TERM OF THIS LIMITED WARRANTY. NO WARRANTIES, WHETHER EXPRESS OR IMPLIED, WILL APPLY AFTER THE LIMITED WARRANTY PERIOD HAS EXPIRED. ESCO DOES NOT ACCEPT LIABILITY BEYOND THE REMEDIES PROVIDED FOR IN THIS LIMITED WARRANTY OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES, INCLUDING, WITHOUT LIMITATION, ANY LIABILITY FOR THIRD- PARTY CLAIMS AGAINST YOU FOR DAMAGES, FOR PRODUCTS NOT BEING AVAILABLE FOR USE, OR FOR LOST WORK. ESCO'S LIABILITY WILL BE NO MORE THAN THE AMOUNT YOU PAID FOR THE PRODUCT THAT IS THE SUBJECT OF A CLAIM. THIS IS THE MAXIMUM AMOUNT FOR WHICH ESCO IS RESPONSIBLE. Formalin Vaporizer

6 iv These Terms and Conditions shall be governed by and construed in accordance with the laws of Singapore and shall be subject to the exclusive jurisdiction of the courts of Singapore. Technical Support, Warranty Service Contacts USA: Singapore: Global Helpdesk: Visit to talk to a Live Support Representative Distributors are encouraged to visit the Distributor Intranet for self-help materials. Product Appendix, Warranty Listings Biological Safety Cabinets, Laminar Flow Cabinets, HEPA-Filtered Cabinets (except Streamline brand) Laboratory Fume Hoods Ductless Fume Hoods Cleanroom Equipment Laboratory Ovens and Incubators CO 2 Incubators Containment/Pharma Products Ultralow Temperature Freezer The warranty periods for BSC may vary by country. Contact your local distributor for specific warranty details. 1 year limited. 3 years limited for Ascent Opti's, 5 years for Ascent Max's. 1 year limited. 1 year limited. 2 years limited. 2 years limited. 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 time so the warranty will go into effect at approximately the same time the equipment is delivered to the user. The warranty protection extends to any subsequent owner during the warranty period. Distributors who stock Esco equipment are allowed an additional four months for delivery and installation, providing the product is registered with Esco. User can register product online at or complete the warranty registration form included with each product. Policy updated on 12 th Apr 2011 (This limited warranty policy does not apply to products purchased before 12 th Apr 2011)

7 v 1. Products Covered Esco Formalin Vaporizer Electrical Rating V AC, 50Hz, 1Φ FV V AC, 50Hz, 1Φ FV Safety Warning Anyone working with, on or around this equipment should read this manual. Failure to read, understand and follow the instructions given in this documentation may result in damage to the unit, injury to operating personnel, and / or poor equipment performance. Any internal adjustment, modification or maintenance to this equipment must be undertaken by qualified service personnel. The use of any hazardous materials in this equipment must be monitored by an industrial hygienist, safety officer or some other suitably qualified individual. Before you process, you should thoroughly understand the installation procedures and take note of the environmental / electrical requirements. In this manual, important safety related points will be marked with the symbol. If the equipment is used in a manner not specified by 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 regulations. 4. European Union Directive on WEEE and RoHS The European Union has issued two directives: Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) This product is required to comply with the European Union s Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96/EC. It is marked with the following symbol: Esco sells products through distributors throughout Europe. Contact your local Esco distributor for recycling/disposal. Directive 2002/95/EC on Restriction on the use of Hazardous Substances (RoHS) With respect to the directive on RoHS, please note that this hood falls under category 8 (medical devices) and category 9 (monitoring and control instruments) and is therefore exempted from requirement to comply with the provisions of this directive. Formalin Vaporizer

8 vi

9 vii Declaration of Conformation In accordance to EN ISO/IEC :2010 We, Esco Micro Pte. Ltd. of 21 Changi South Street 1 Singapore, Tel: Fax: declare on our sole responsibility that the product: Category : Formalin Vaporizer Brand : - Model : FV-001 in accordance with the following directives: 2006/95/EEC : The Low Voltage Directive 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 :2010 EMC : EN :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 information is available on request from Esco. XQ Lin Group CEO, Esco This Declaration of Conformity is only applicable for 230V AC 50Hz units Formalin Vaporizer

10 viii

11 1-1.1 About Esco Formalin Vaporizer Esco formalin/ammonia vaporizer features a fully automatic decontamination and neutralization cycle which will switch off the heating cycle as soon 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. Manufactured year - The year of manufacture. Formalin Vaporizer

12 2 1.3 Quick View Esco Sentinel Microprocessor Control System 2. On/Off switch 3. Formalin Tank Caps 4. Ammonia Tank Caps 5. Stainless Steel Grip Handle

13 3 2.1 Sentinel Control System MENU SET UP DOWN 1. Up ( ) and Down ( ) Arrow Button o Move the menu options upwards and downwards. o Increase and decrease corresponding value inside one of the menu options. 2. Set or Mute Button o Choose the menu or sub-menu currently displayed on the LCD screen. o Proceed to 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 SET TIME HH:MM SET ADMIN PIN XXXX MENU PRE PROC TIME CONTACT TIME NEUTRAL TIME START PROCESS MM HH:MM HH:MM This part of the menu tree is only accessible before the decontamination process starts RESET DEFAULT RESUME STEP SKIP STEP CANCEL STEP This part of the menu tree is only accessible after the decontamination process starts Formalin Vaporizer

14 Before Decontamination Process Start Some of the menu in the Formalin Vaporizer can only be accessed before the decontamination process starts. This menu enables the operators to customize the vaporizer settings (preprocessing time, contact time and neutral time) according to their specific needs. During the decontamination process; this menu can no longer be accessed Set Time Users can set the time by increasing/decreasing the hour and minute values. The correct time will be maintained even after the unit is turned off. MENU SET TIME HH:MM TIME SET Set Administrator PIN This menu enables the operator to enable and disable admin PIN. The formalin vaporizer default admin PIN condition is disabled; however the operator can enable it by setting an admin PIN. To disable the admin PIN; set it to MENU SET ADMIN PIN XXXX CONFIRM PIN? Pre Processing Time Pre proc time or pre-processing time is the time between the formalin vaporizer start until the time the formalin vaporizing step starts. This time allows the operator to finish preparing the unit or room for decontamination i.e.: sealing a biological safety cabinet. The default preprocessing time is 10 minutes; however the operator can set the time between 01 and 59 minutes. MENU PRE PROC TIME MM PRE PROC TIME SET 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.) blower to circulate the formalin and enable the vapor to reach each crevice of the unit. The default contact time is 15 hours; however the operator can set it between 04:00 to 17:59. MENU CONTACT TIME HH:MM CONTACT TIME SET Neutral Time Neutral time is the ammonia residence time after the ammonia vaporizing step ends. The ammonia is needed to neutralize the formalin. During the ammonia vaporizing period (25%, 50%, 75% and 100% vaporized); it is a good idea to turn on the unit (biological safety cabinet, etc.) blower to circulate the formalin and enable the vapor to reach each crevice of the unit. The default neutral time is 8 hours; however the operator can set it between 01:00 to 17:59 MENU NEUTRAL TIME HH:MM NEUTRAL TIME SET Start Process This will start the decontamination process. The process will start with pre-processing step, and continue with formalin vaporizing step, contact time step, ammonia vaporizing step and finally neutral time MENU START PROCESS START PROCESS? EVACUATE

15 Reset Default This will start the decontamination process. The process will start with pre-processing step, and continue with formalin vaporizing step, contact time step, ammonia vaporizing step and finally neutral time step. MENU RESET DEFAULT READ MANUAL PRESS SET After Decontamination Process Start This menu can only be access during the decontamination process 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. MENU RESUME STEP CONFIRM? Skip Step This allows you to skip a step in the decontamination process. MENU SKIP STEP SKIP STEP? Cancel Process This allow you to cancel the decontamination process altogether. MENU CANCEL STEP CANCEL PROCESS? Formalin Vaporizer

16 6

17 7 3.1 Formalin/Paraformaldehyde Decontamination Typically the decontamination is performed using formalin gas by either vaporizing 37% formalin solution or by de-polymerization of solid paraformaldehyde. Despite its widespread usage for decontamination, formalin presents the following health risks: External contact can cause irritation to skin, eyes, and mucous membranes. Inhalation in small concentrations can cause coughing, nausea, and diarrhea. Inhalation in large concentrations can cause convulsions, coma, and death. Long term exposure can cause cancer. Although the Permissible Exposure Level (PEL) for formalin is 0.75 ppm, many scientists believe that there is no safe level of carcinogen exposure to humans. Therefore, typically the room must be evacuated when the decontamination process is performed, which leads to lab down time. The use of formalin decontamination also has other disadvantages: The process is time-consuming. The certifier needs to pulse the BSC fan to circulate the formalin vapor. This can dislodge the tape holding the plastic sheet covering the exhaust filter. Due to excessive residue extensive cleaning must be done after decontamination and before use. The formalin decontamination process can require an extended period of time as outlined below: According to OSHA [Occupational 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 , Occupational Safety and Health Standards, OSHA (Occupational Safety and Health Administration), U.S. Department of Labor: OSHA Formaldehyde Fact sheet (PDF format) formaldehydefactsheet.pdf No. Process Time 1 Set-up & sealing the BSC to make it air tight 1 hour 2 Formalin vaporization ½ hour 3 Formalin contact time to obtain target log of 4-6 kill 8 10 hours 4 Ammonia vaporization to neutralize formalin ½ hour 5 Ammonia contact time to neutralize formalin 2 hours 6 Exhausting the ammonia residue 1 hour 7 Tear-down & cleaning the (substantial) residue 1 hour TOTAL without ammonia neutralization 10½ 12½ hours TOTAL with ammonia neutralization hours Ammonia is used to neutralize formaldehyde. OSHA prescribes the ammonia STEL is 35 ppm for 15 minutes exposure, 4 times a day, minimum of 60 minutes in between exposure. Due to the adverse health effect of formalin gas, its use has been banned in Germany, Austria, and Switzerland. Other European countries are expected to follow suit. Two primary candidates to replace formalin decontamination are chlorine dioxide gas and hydrogen peroxide vapor. Formalin Vaporizer

18 8 3.2 Common Equipment Used in Decontamination Common Equipment Device to measure formaldehyde concentration FormaldemeterR 400 has been found to be suitable and can be obtained from: PPM Technology (UK) - Device to measure ammonia concentration DragerR-Tubes and AccuroR pumps have been found to be suitable: Dragerwerk AG (Germany) - Tubes with a measuring range of ppm are recommended Formalin vaporizer o FV-001 Formalin Vaporizer V, 50/60 Hz o FV-002 Formalin Vaporizer V, 50/60 Hz Esco Micro Pte. Ltd. - Spore strips (optional) to verify decontamination efficacy Appropriate PPE A solid front-back closing, full body, long-sleeved disposable lab gown Disposable shoe covers Disposable surgical/pvc gloves for hand protection Note: Gloves should be pulled over the knitted wrists of the gown rather than being worn inside. Double gloving should be considered. Gloves must be worn while handling formalin and ammonia solutions. Compared to latex gloves, Nitrile gloves exhibit higher resistance to formaldehyde and are less likely to cause allergic skin reactions. Hence Nitrile gloves are preferred over latex gloves. Full-faced mask with a disposable dust and mist respirator. The face shield should be wiped clean with a suitable tissue and water each time after using it 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 you re using formalin vapor/ paraformaldehyde gas and chlorine dioxide gas. A warning sign should be pasted on the door of the lab to warn all personnel. No personnel should enter the lab until the procedure is complete and the decontamination agent s concentration has been verified to be within safe limits. 3. Prior to starting the procedure, contingency plans should be drawn for possible incidences of breach in the unit seal, leading to leakage of decontamination agent into the room. You should properly study the ventilation design of the room and should keep appropriate equipment on standby so the agent can be vented in the event of a leakage. One way of doing this would be to connect a flexible hose to a small exhaust fan which can vent the contaminated air into an adjacent fume hood. Special care should also be taken in case the air in the laboratory is re-circulated to other parts of the building. In such a case, a leakage could even necessitate evacuation of other parts of the building. 4. All interior work zones and surfaces of the unit should be decontaminated with a suitable disinfectant before performing gaseous decontamination.

19 9 3.4 Recommended Decontamination Sealing Method For Unit without Ducting Put the decontamination bag to enclose the entire BSC and support stand Use the 50 mm wide aluminum tape to seal the gap between the decontamination bag and the floor. To compensate for areas where the decontamination bag must turn, use multi section tape. Ensure that the two layers of tape overlap at the end points 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 part of the decontamination bag on top of the aluminum tape, and then seal it with another layer of aluminum tape. Use multiple layer of aluminum tape (at least 2 layers) on both directions to ensure leak tightness. Formalin Vaporizer

20 10 The BSC is ready for formalin decontamination For Unit with Ducting For ducted Unit, you will need to cut a portion of the bag to accommodate the ducting system. The decontamination method itself is basically the same as the non-ducted Unit shown above with some additional 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.

21 Decontamination Process There are two alternative combinations of decontaminants and their corresponding neutralizers that are commonly used: 1. 37% formalin solution (HCHO) with 25% ammonia solution (NH4OH) being the neutralizer 2. Paraformaldehyde with ammonium bicarbonate (NH4CO3) being the neutralizer 3. The decontamination processes carried out using these two combinations are slightly different. Both these processes are discussed in details. It is very important to ensure compliance with local laws and regulations with respect to the above mentioned techniques. For instance, if local environmental regulation prohibits the release for formalin vapor into outside environment, the formalin vapor needs to be neutralized by ammonia first, before their byproduct can be exhausted outside. Connecting a temporary duct to the Unit, with the gas being released into a fume cupboard. Connecting a temporary duct to the external atmosphere using a temporary form connection. Using the existing duct connection of the Unit to exhaust the gas (This is applicable only if the Unit is itself ducted). It is very important to ensure compliance with local laws and regulations with respect to the above mentioned techniques. For instance, if local environmental regulation prohibits the release for formalin vapor into outside environment, the formalin vapor needs to be neutralized by ammonia first, before their byproduct can be exhausted outside Formalin Ammonia Combination Calculate the amount of 37% formalin, 25% ammonia, and water required, which is 85 ml 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 tank because it will not assist in the decontamination process. 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. 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. Allow the formalin vapor a minimum 6 hours (10 to 12 hours is preferable) contact time inside the Unit. Once the formalin decontamination time is reached, start the apparatus containing 25% ammonia to neutralize the formaldehyde. 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. 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 formalin 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 Paraformaldehyde Ammonium Bicarbonate Combination Additional apparatus needed: Heating device (e.g. frying pan) Aluminum foil Formalin Vaporizer

22 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.

23 Completion Steps Check the ammonia concentration in room air Check the formaldehyde concentration in room air at the end of decontamination cycle, prior resuming work on the BSC Check the formaldehyde and ammonia concentration in the BSC During the procedure, until the area is determined to be safe, a full face gas mask equipped 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 Remove the disposible gown and gloves carefully and wash hands using germicidal soap thoroughly Remove the decontamination bag that enclosed the BSC Remove all apparatus from inside the BSC 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 o Downstream HEPA filter Place similar strips outside the decontamination room for positive control (optional). Remove all the spore strips and place in trypticase-soy broth and incubate for 2 days at 37 C. If there is no growth of bacteria inside the broth (the broth remains clear), the decontamination procedure has been successfully verified. Formalin Vaporizer

24 14

25 APPENDIX

26

27 Equipment : Serial Number : Person in Charge : 1. This log record should be used by the operator to record any new agent that has been introduced to the equipment during its operation, 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 : Cell Phone Number :

28