A0003pg2.docx

1. Is a hinged “gull-wing” window necessary, and can it be provided as an optional addition Line Item? (Supporting information below)

0. The provided specification states that the unit supplied “Must meet all the requirements of a Class III Biological Safety Cabinet defined by the Federal Register and CDC/NIH publication ‘Biosafety in Microbiological and Biomedical Laboratories’ 5th Edition”.

0. Within the provided Spec, one of the requirements states “The working chamber must have a hinged gull wing door that can be opened to allow loading of equipment and instruments”.

0. On page 297 of the BMBL 5th, it states that The Class III BSC “is a gas-tight enclosure with a non-opening view window”.

0. Thus a Gull-wing window directly contradicts the BMBL.

1. Answer: Yes, the working chamber must be able to be opened to allow the loading of equipment and instruments. A hinged gull wing door is the preferred method that is currently utilized on other Class III BSCs at the NCAH. It can be added as an optional line item.

1. Can the quoted Class III BSC provide Turbulent Airflow within the working and pass-thru chambers as opposed to unidirectional (laminar) airflow? (Supporting information below)

1. The provided specification states that the unit supplied “Must meet all the requirements of a Class III Biological Safety Cabinet defined by the Federal Register and CDC/NIH publication ‘Biosafety in Microbiological and Biomedical Laboratories’ 5th Edition”.

1. Within the provided Spec, it says the unit supplied shall be constructed such that “Both the primary work chamber and the pass-through chamber incorporate vertical, top to bottom, unidirectional air flow”.

1. On page 297 of the BMBL 5th, with the section defining the Class III BSC, it states that “Depending on the design of the cabinet, the supply HEPA filter provides particulate-free, albeit somewhat turbulent, airflow within the work environment. Laminar airflow is not a characteristic of a Class III cabinet”.

1. Thus unidirectional (or laminar) airflow is not standard for a Class III BSC.

1. Answer: The BSC design must incorporate that both the primary work chamber and the pass-through chamber incorporate vertical, top to bottom, unidirectional air flow. This is required to minimize cross contamination when multiple samples may be processed at the same time.

1. Can a polycarbonate view screen be quoted as standard with an optional line item for glass?

2. Note that polycarbonate windows are compatible with all of the chemicals listed in Amendment 2, assuming all cleaning and decon processes are followed by fresh water wipe down.

2. Glass front windows are non-standard on Class III BSCs and expensive to replace. They are often broken by certifiers and operators “over-torqueing” bolts securing gloveports and the window itself in place, thus they are unable to be warrantied and not recommended.

1. Answer: Yes polycarbonate can be quoted as standard with an optional line for glass. View screens can be made of other material, providing that the manufacturer provide documentation that the other material be equivalent or greater than the 3/8” mirror quality scratch resistant safety glass, in terms of optical clarity, scratch resistance and safety.

1. Since the unit is to be hard-ducted out of the facility, is there a requirement for the Class III Manufacturer to provide a secondary HEPA filter and motor/blower, or will these services be provided as part of the house exhaust?

1. Answer: The house exhaust can provide secondary HEPA filtration and controlled negative static pressure. A secondary HEPA exhaust and/or motor/blower are not required.

1. Is there a requirement for installation and certification services, or only surface freight?

1. Answer: Installation and certification is not required, only delivery to the NCAH.