Frequently Asked
Questions

USP<800> is meant to work in conjunction with <797>, so a lot of the regulations are harmonious. There are a few exceptions, and expect <797> to be updated with these new changes shortly. USP<800> states that the negative pressure room has to be between 0.01 and 0.03 inches of water column more negative than the surrounding areas. <797> didn’t have an upper limit. C-PECs now have to be located within a negative pressure room for all HD work. This does not have to be a CACI. The last difference is that all HD work needs to be done in a C-PEC.

Certain chemicals have been shown to be harmful to the RH sensor. This will cause an inaccuracy in the ability of the RH sensor to identify the true internal humidity. Do NOT use any chlorine-based chemicals (e.g. bleach). Baker recommends using the following for surface decontamination:

• Diluted Hydrogen Peroxide
• Ethanol

After cleaning, a rinse with sterile distilled water is recommended. Also, allow all fumes to exit the incubator before closing the door and resuming operation.

No, the BioChemGARD 401 and 601 does not require a special exhaust control valve in order to operate the ReadySafe mode feature.

The ReadySafe feature is standard on all BCG401 and BCG601 biosafety cabinets and activates by lowering the viewscreen to its fully closed position. Once the viewscreen is closed, the BCG supply fan speed is automatically decreased and turns the fluorescent lamp off, reducing the biosafety cabinets total energy consumption. In the ReadySafe mode, the facility exhaust system requirements will not change, pulling the required air through the cabinets bypass armrest and into the front worksurface perforation maintaining the cabinets personnel and product protection characteristics.

For additional energy savings, the customer may choose to equip the laboratory with a multi-position exhaust control valve to reduce the volume of conditioned lab air exhausted from the space. This is not a requirement for the BCG401 and BCG601 but rather an optional configuration supplying dry Form C contacts to communicate with the facility exhaust valve. If this option is being considered, room air balance and pressurization must be taken into account.

Baker does not recommend more than one user working through the front access opening of any Class II biosafety cabinet. Although our Class II products have undergone a rigorous test evaluation using microbial spores to ensure personnel, product, and cross contamination protection, these tests are performed in an ‘at rest’ condition as stated in NSF Standard 49.1 When used properly, Class II BSCs have been shown to be highly effective in the reduction of laboratory-acquired infections and/or hazardous drug exposure, the protection of product from outside contaminants, and protection of cultures from cross-contamination. Currently there are no ‘use restrictions’ within the biosafety industry regarding simultaneous use; therefore, a risk assessment should be performed by the individual most familiar with the product being considered for use. A biosafety cabinet is a valuable supplement to, but not a replacement for, good laboratory technique and safe practice.

Neither USP <797> nor <800> specifically calls out a sink location within an ante room, only that it is a critical component in reducing microbial contamination from entering the buffer area. For most applications that we have seen, the location of the sink is on the clean side of the anteroom or on the opposite line of demarcation used for hand and forearm washing after head, facial and booties are donned. It’s important to remember that sinks can be a major source of contamination; therefore, strict emphasis on environmental monitoring and gowning procedures must be made.

We do recommend, however, that our customers employ their own risk assessment, relative to applicable regulatory guidelines, facility requirements, and standard operating procedures in order to derive at the right decision for them.

Yes, the fan will be disabled when there is a door opening. Air from the outside will influence the chamber’s ability to maintain a warm, humid environment essential to cells and cell growth. If the fan were to run when the door is open, moisture and heat will escape and be blown out of the unit, thereby increasing the amount of time it takes to recover the environment. When the door closes and the fan is turned back on, Cultivo will return to better than ISO Class 4 (Class 10) conditions within 60 seconds.

The capacity of the unit to maintain plate and fluid moisture has not been shown to pose a problem within the Cultivo design. The design of petri dishes and T-flasks, is supposed to allow gas exchange into the culture without drying. Turbid air within the chamber and any upward airflow would actually have a much larger impact (when dishes are covered and capped, air can enter in more easily from the bottom than from the top). Cultivo’s uniform down-flow air provides ISO Class 4 Air to the chamber at a rate which will not impair efficient gas exchange or dry out media / cultures. Please review our test reports on air cleanliness and cell growth.

Since we know the water reservoir to be the most likely source of contamination within most incubators, the HEPA filter has been placed after the RH generator.

The Cultivo with evaporative humidification relies on water evaporating from a pan and into the airstream. This method of humidification is capable of providing a 10 minute recovery to our high end set point (92%, +/- 3%). The Cultivo Ultra with ultrasonic humidification (nebulizer) uses ultrasonic vibrations to aerosolize water which is then readily evaporated into the air. This system provides 20% faster humidity recovery and does not require the user to access the chamber in order to refill/replenish/empty a water pan, thereby reducing the likelihood for contaminants to enter the system from the outside.

The supplier provides a useful life claim of 10 years. Baker provides a two year warranty on parts and labor.

Cultivo utilizes a full calibrated, digital humidity and temperature sensor.

A digital humidity and temperature sensor integral to the unit and Cultivo’s proprietary algorithm (InteliCELL) are used to regulate relative humidity in the chamber.

Desired concentration of CO₂ gas is injected into the chamber using solenoid valve. The solenoid value is regulated based on the CO2 sensor and control algorithm (InteliCELL).

Temperature sensors integral to the unit and Cultivo’s proprietary algorithm (InteliCELL) are used to regulate the chambers heaters (direct heat).

The incubator will provide a prompt the user after 8760 hours of operation, indicating that it is time to evaluate whether or not a new HEPA filter is needed. At this point, we recommend that the user contact their local sales professional for assistance.

The life of a HEPA filter in any system is largely contingent upon its use and the environmental conditions found within the laboratory. We expect the HEPA filter to perform sufficiently for many years; however, the system’s ability to maintain optimal performance and, in turn, continue to deliver better than ISO Class 4 conditions (Class 10) for air cleanliness, may become compromised over time. Conservatively, we recommend that the HEPA filter and in-line CO₂ filter be changed on an annual basis. That said, you should consult your biosafety officer, assess the environment found within your laboratory, make your own observation of that particular incubator’s ability to stop the spread of contamination associated with your work in order to determine whether or not it is time to replace your HEPA filter.

Unidirectional HEPA filtered air cascades downward in incubator chamber; Air is drawn into the base across humidity source, then travels up the rear wall plenum to the internal fan, air is discharged upstream of a full face HEPA Filter and returned to incubator chamber.

A direct heat incubators is an air-jacketed incubator, which provides heating elements around the chamber of the incubator to provide precise temperature control and uniformity throughout the chamber.

The Cutivo delivers an air cleanliness rating that is better than ISO Class 4 (Class 10), in accordance with ISO 14644-1 standards for cleanroom and controlled environment applications. This condition is reached within 60 seconds of a door opening. For point of reference, a typical biological safety cabinet provides ISO Class 5 conditions (Class 100).

An alternative to the water-jacketed incubator is the forced air or air jacketed incubator. An air circulation fan placed in the air jacket (between the interior and external chamber wall) ensures uniform temperature distribution in the inner chamber. This type of incubator is easier to set up initially, and will get to its set temperature for the first time more quickly because there is a great volume of air movement.

The airflow is set at the factory for a specific viewscreen height. Other settings will not allow the cabinet to function at optimal efficiency or safety.

Ultraviolet light should not be relied upon as the sole decontaminating agent. Surface disinfection should be performed before and after every cabinet use.

HEPA filters should be replaced if they are damaged or when in-house safety protocol requires filter replacement. Filter replacement occurs when motor/blower can no longer deliver the required airflow due to excessive filter load.

The ultraviolet light should be turned on only when no one is in the room and the viewscreen sash is completely lowered since eyes and skin should not be exposed to this harsh light. This ultraviolet light bulb loses effectiveness over time and should be replaced when intensity drops below optimal level.

The life of the filter is determined by how it is used and how often. Under normal laboratory conditions, you can expect anywhere from 5 to 10 years of use from a filter in a Baker cabinet. Misuse or heavy dust load within the cabinet will shorten any filter's lifetime.

Consult your lab director or local safety officer on the appropriate disinfectant. Many people use liquid Lysol, isopropyl alcohol or a 10% bleach solution. However, when using any disinfectant, after using, then rinse thoroughly with water as soon as possible. Although chlorine bleach is a known corrosive on stainless steel, the thorough wash down will help to remove residue.

Most times a problem with your equipment needs the attention of a qualified Safety Professional who has been trained in biological safety cabinets or your certifier. There are few things, however, a user can try in order to troubleshoot the problem. You can use the information you obtain to relay to your Certifier if you need to call him/her. First, check the blower switch. Is it in the on” position? If yes

For normal operation, the viewscreen must be placed to allow an opening of 8” or 10”. The sash alarm will be activated whenever the sash is raised or lowered from this level. To mute the audible alarm, press the alarm reset button. The indicator will continue to flash. After five minutes, the alarm will sound again to remind you to lower the viewscreen. You may press the alarm reset switch again to mute the alarm for another five minutes. The alarm will sound again if the viewscreen is not in the proper position.

It may be helpful to use a magnetic sponge or squeegee with the appropriate disinfectant.

Consult your lab director or local safety officer on the appropriate disinfectant. When using the disinfectant you should clean well with detergent, then rinse with water. Do not use anything that may harm or corrode stainless steel.

• Turn on blower and fluorescent light, close drain valve.
• Check Grills for obstructions and disinfect all interior work surfaces.
• Place all materials and equipment needed in cabinet.
• Adjust viewscreen to proper position.
• NEVER use with viewscreen above factory set mark.
• Allow unit to run at least three minutes before loading.
• RESTRICT traffic in the BSC vicinity.

• Load only items needed for procedure.
• Do not block rear or front exhaust grilles.
• Disinfect exterior of all containers before commencing.
• Arrange materials to minimize movement within cabinet.
• Once cabinet is loaded, lower viewscreen, wait three minutes to purge contamination from work area.
• Non-sterile items should never be upstream of sterile items

• Wash hands with germicidal soap before and after procedure.
• Wear sterile gloves and lab coat/gown; use aseptic technique.
• Avoid blocking front grille! Work only on or over solid surface, adjust chair so armpits are at elevation of lower window edge.
• Avoid RAPID movement during procedures, within BSC and room.
• Move hands and arms straight into and out of work area, never rotate hand/arm out of work area during procedure.
• Move laterally in work area.

• After completing work, run BSC three minutes BEFORE unloading
• Disinfect exterior of all containers BEFORE removing.
• Decontaminate interior work surfaces of BSC with disinfectant.

Baker recommends that this unit run continuously. If the unit is turned off, viewscreen should be closed completely. Allow unit to run for at least three minutes before loading.

Copies of USP <797> are available from USP. Order USP 27-NF General Chapter 797 Pharmaceutical Compounding

Since Baker is not an expert on specific agents, we cannot answer this question. It will be helpful for you to contact your Biological Safety Officer, the Center of Disease Control or the appropriate national agency for answers to this question. Baker can recommend references for this use.

Yes, Baker offers a 3-foot SterilGARD e3I Advance Model 303.

In 2008, NSF Standard 49 was changed to eliminate the Type A1 allowance of positive pressure plenums adjacent to the room. Because of this change, the primary difference between an A1 and an A2 now is the minimum designed intake air velocity only. An A2 cabinet must have a minimum of 100 FPM intake velocity, allowing it to be used for volatile chemicals and radionuclides adjunct to microbiological studies, if properly exhausted outdoors via a canopy exhaust connection. A Type A1 cabinet can have a minimum face velocity of 75 FPM, which excludes it for use with volatile chemicals or radionuclides, even if properly fitted with a canopy exhaust connection.

Outstanding reliability and a long life cycle designed into all our products have made Baker the industry standard. We're proud to offer a 3-year warranty against defects in material or workmanship on our standard products and a 1-year warranty on our chemical Fume Hoods and Custom Products. (And by the way, we'll be glad to answer any specific warranty questions — just get in touch!

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If the test report is misplaced, simply contact Baker with the model number and serial number on the front name tag of the cabinet for a replacement and we will do our best to provide a duplicate.

Baker did collaborate on one video, Introduction to Biological Safety Cabinets”. This and other training videos are available through the Eagleson Institute

Baker ships the unit to the loading dock. Should you need an inside delivery, we can ship the unit via moving van or you can contact a local mover who will bill you directly. Your local Baker Sales Representative can help you in making these arrangements.

This depends on the policy of your institution or advice of industrial hygienist, safety officer or other qualified person. It is suggested that testing be carried out at regular intervals, at least annually, as well as after relocation and filter change.

The ideal location is a dead-end corner of the laboratory, away from personnel traffic, vents, doors, windows and other sources of disruptive air currents.

No. Baker provides a comprehensive test report with every cabinet, but certification must be performed on-site, with the cabinet in place. Certifiers are independent testing agencies staffed by trained professionals. See the list of certifiers on our web site or speak with a Baker Customer Service Representative for those in your area.

The StediVolt is a unique voltage compensation speed controller for maintaining air balance insuring product and personnel protection over a range of incoming voltage changes.

HEPA stands for High Efficiency Particulate Arrestance Filter. Its efficiency is rated at least 99.97% efficient on particles of 0.3 microns in size. Baker uses scan (probe) tested filters for leak-free assurance.

A petcock is a service fixture with valve within the workspace for gas, air or vacuum.

UL is the Underwriters Laboratory, a testing agency for safety and electrical.

CSA is the Canadian Standard Association, is a testing agency for safety and electrical.

The performance envelope is the operational airflow balance extremes within which a given cabinet design will pass the microbiological aerosol tracer test for personnel and product protection.

The AFM (Airflow Monitor) is an audio-visual mass airflow alarm system which indicates when exhaust airflow drops below a set point. A warning light and buzzer are activated when exhaust airflow drops below a set point.

NSF is the National Sanitation Foundation, Standard No. 49 is the design, construction and testing document which establishes a minimum standard for Class II biological safety cabinets.

A stainless steel air diffuser creates a faster airflow immediately behind the window and a slower airflow over the center. The result is a more impenetrable air barrier in the front of the cabinet creating more product and personnel protection.

This instrument measures air pressure (suction to the blower) and may be found on some SGII models. The lights signal you if there's blockage of the front perforated grilles, if the viewscreen is not in the proper position or if the blower is not on. A steady green light on the Air Pressure Monitor about halfway up the bar graph means your blower is working. After you lower the sash to the fully closed position, you will notice the steady green light at the top of your Air Pressure Monitor has traveled to the top of the bar graph. The steady green light here means that the suction to the blower has increased. If the SG II's sash is closed, the blower is on, the unit is running safely. If you choose to turn off the blower, you will notice a steady red light at the bottom of the Air Pressure Monitor and will hear a beeping sound. Lower the sash to keep particles from migrating into the work area and to silence the alarm.

This safety feature indicates that the viewscreen is not set at the proper height. Slowly adjust it to an 8 opening. When the viewscreen arrives at that height

Yes, it is at highest efficiency at particulates above and below 0.3 micrometers, thus filtering out viruses as well as viruses carried on larger particles.

The receptacle switch activates the duplex electrical receptacles within the hood; it is on a separate circuit from the motor/blower.

No, Baker uses a variety of motor drive technologies to provide the safest and most efficient airflow.

The standard power cord on most units is the 115V, single phase 20 amp power cord (NEMA 5-20P); however, we supply the International market with power cords to meet their specific standards. Units exceeding 16 amp power load have a junction box for power cords.

Yes, if your cabinet originally had a stedivolt. If you have an older speed controller, those are also still available. Your local certifier can install either component.

This metal T” wrench is used to release the rotolocks securing the HEPA filter inside the EdgeGARD®.

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Three of the key advantages of a combination sash are that it provides multiple sash positions that are ergonomically helpful, it serves as a physical barrier to protect the user's breathing zone and it delivers energy efficiency by requiring less exhausted air to maintain 100 LFPM, but this merely scratches the surface.

We've built in safety features to protect cabinet users and ensure that the light is used properly. The UV/germicidal light switch and cabinet lighting cannot be turned on simultaneously. A UV interlock switch assures that UV illumination occurs only when the sash is fully closed. To operate the UV light, leave the blower on, lower the sash until it's fully closed, turn off the fluorescent lights and then turn on the UV light.

One petcock is standard on most cabinets; three apertures fitted with plugs are provided for the installation of additional service fittings as needed. [The SterilGARD is furnished with one petcocks as standard equipment, while the EdgeGARD does not include petcocks.] Refer to your Baker Catalog for this information on any particular cabinet.

The magnehelic gauge provides a gross” or approximate indication of HEPA filter loading

The advantages of both kinds of glass have been carefully evaluated by Baker engineers. Tempered glass tends to shatter, while safety glass will crack but typically does not shatter. Given the nature of the laboratory environment, it's our determination that this characteristic provides better safety protection for Baker users.

The adaptations may include: microscope setup; small clinical centrifuge; enclosure setup for extra large work area (i.e.: shaker bath, constant temperature bath). We have experience with a broad range of applications. Contact us to discuss your particular requirements.

The Baker product has a noise level below the NSF Standard of 67 dbA.

The NCB, SterilchemGARD, and BiochemGARD. The AFM is optional on other BSC's.

This plug allows access to the air damper which should only be adjusted by a certification specialist to balance the cabinet's airflow. On some models this plenum may be contaminated if the cabinet has been used, requiring decontamination before plug removal.

We have information that may have the answers you are looking for. Our Products Catalog can provide you information about each model of cabinet we sell and its exhausting requirements. Baker has written two papers on this topic. Their titles are Using Thimbles to Connect Biological Safety Cabinet to Variable Air Volume (VAV) Systems” (Acumen

The SterilGARD does not have to be connected to an exhaust duct to provide its rated level of performance; however, you or your safety officer may want to confirm that the installation meets all relevant local and state codes pertaining to your application. Obviously, it's important to consider carefully the agents you'll be working with to ensure the appropriate level of product, personnel and environmental protection. Again, your safety officer can be most helpful in meeting these concerns. If external ducting is indicated, your SterilGARD can be readily adapted. When not ducted, SterilGARD is classified as Class II Type A1. When ducted, it becomes a Class II Type A2.

It is important to leave approximately 4 inches. If the ceiling is this close or closer, an accurate measure of exhaust flow can be obtained only by using a proper direct intake flow method.

This is appropriate when a unit is connected to an in-house exhaust system. Check with your institution's HVAC specialist for further information.

Yes, Baker has two GSA Contracts for Class II BSCs as well as Clean Benches and Isolators.

The Baker Clean Bench (EdgeGARD) is a primary engineering control (PEC) designed to help you achieve compliance with the ISO 5 internal air cleanliness requirements of USP<797> when properly used and maintained. ISO Class 5 is maintained during the ingress and egress of materials, during simulated compounding activities, and when subjected to a simulated process-generated cross-contamination challenge. Each facility should have appropriate standard operating procedures (SOPs) for material handling and use of personal protective equipment (PPE) to avoid surface contamination (aseptic conditions). Ultimately it is the responsibility of the certifying professional in your area to validate that the Baker Clean Bench has been installed properly, meets all test report specifications and verifies the ISO Class 5 work area environment as indicated in USP <797> (section: Environmental Quality and Control, sub-section: Placement of Primary Engineering Controls) and the CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2006).

Note: All Baker PECs are delivered with a factory test report that includes data for the CETA testing (CETA Sterile Compounding Facilities CAG-003-2006) on that particular model.

According to the official changes to USP<797>, the Compounding Aseptic Isolators (CAI) and Compounding Aseptic Containment Isolators (CACI) are Restricted Access Barrier Systems (RABS) and not Pharmaceutical Isolators.

• A Restricted Access Barrier System or RABS (like the Baker SterilSHIELD CAI and ChemoSHIELD CACI) are considered ‘open’ systems because they transfer materials in and out of the Main ‘Working’ Chamber through an air lock or pass-through chamber. A RABS (CAI/CACI) must be placed in an ISO class 7 room and the required Beyond Use Dating (BUD) for the drug(s) as described in USP797. Therefore, Baker's SterilSHIELD and ChemoSHIELD will be treated no differently than a SterilGARD Biosafety Cabinet (BSC) or EdgeGARD Laminar Airflow Workstation (LAFW) with regards to BUD.
• A Pharmaceutical Isolator uses direct interfaces in an out of the Isolator, such as a Rapid Transfer Port (RTP). An Isolator can be placed in an ISO Class 8 room and be used to compound the maximum allowed Beyond Use Dating (BUD) of the product typically greater than 12 hours. Perhaps, though the biggest difference between a RABS and a Pharmaceutical Isolator is the Isolator has the provision to use a gaseous decontamination process when loading the chamber to practically eliminate product containment concerns.