Class_IIIBSC_Specifications.pdf

8‐foot glove box specifications for BioTesting Division, ECBC West, Dugway Proving Ground, Utah.

General:

Microbiological activities are conducted by the U.S. Army in developing measures to identify, detect, and protect again infectious agents and toxins. Class III biological safety cabinets, also known as gloveboxes, are gas‐tight (meaning no leak greater that 1X10‐7cc/sec with 1% test gas at 3 inches pressure Water

Gauge) work areas designed to protect the worker, the environment, and the sample from contamination. The worker can manipulate materials inside the class III biological safety cabinet by using arm‐length gloves attached to different areas of the cabinet. Outside air is filtered through a HEPA filter prior to entry and air leaving the class III biological safety cabinet is filter through two (2ea) HEPA filters before being vented back into the lab space. Samples, materials, and instruments are introduced or removed from the class III biological safety cabinet via airlock and pass‐through doors. All class III biological safety cabinets will be constructed in accordance with the definitions for this type of equipment as defined by:

1. Department of the Army Pamphlet 385‐69, Safety Standards for Microbiological and Biomedical

Laboratories, 2013

2. U.S. Centers for Disease Control/National Institutes of Health publication Biosafety in

Microbiological and Biomedical Laboratories, 5th edition (BMBL) 5th Edition, 2009

3. National Sanitation Foundation/American National Standards Institute Section 49 Biosafety

Cabinetry: Design, Construction, Performance, and Field Certification, Annex E, 2016.

BioTesting Division, ECBC West, at Dugway Proving Ground, Utah requires a Class III Biological Safety

Cabinet (hereafter referred to as a glovebox) as specified below:

Specifications for the glovebox:

Component Specification

Final glovebox quantity Quantity is One (1 each)

Design Manufacturer shall provide draft and final design drawings for written approval by customer prior to starting physical glovebox fabrication.

Delivery lead time Manufacturer shall deliver completed glovebox to the customer within 24 weeks after final design approval.

Glovebox ‐ internal work area dimension (W x D x H) 96”x 32” x 36”

Glovebox ‐ overall dimensions Fully assembled dimensions are not to exceed 150” x 34” x 98” (W x D x H). The lab ceiling working height is 98” (floor to light fixtures) and the total lab ceiling height (floor to ceiling) is 137”. All components must fit through a 34” wide x 83” high mandoor. Components that will cause the overall glovebox to exceed the 34” width and 83” height must be removable to fit the glovebox through the mandoor and be reassembled by the operator in the laboratory.

Glovebox construction All welded metal components must be made of corrosion resisting stainless steel type 304 and 316L in 12 and 14 gauge appropriate for glovebox construction/use.

Glovebox construction – passage doors The hinges and latch/knob areas of all passage doors shall be sealed to airtight requirements (meaning no leak greater that 1X10‐7cc/sec with 1% test gas at 3 inches pressure Water Gauge).

Glovebox – gaskets All gaskets shall be made of a material, preferably silicon, suitable to maintain a gas‐tight seal (meaning no leak greater that 1X10‐7cc/sec with 1% test gas at 3 inches pressure Water Gauge).

Interior design ‐ finish The interior of the cabinet must be constructed with smooth finishes that can be easily cleaned and decontaminated.

Interior design – corners and bend Interior coved corners and radius bends.

Interior design – sharp edges All burrs and/or sharp edges on cabinet finishes must be eliminated to reduce the potential for cuts and tears of gloves.

View screens Front, rear, and pass‐through box view screens made of materials equivalent or greater than 3/8”mirror quality scratch resistant safety glass.

The manufacturer must provide documentation that materials other than glass are equivalent or greater in terms of optical clarity, scratch resistance, and safety.

View screen – front Front view screen should bolt on allowing access to install and remove contents too large to fit through pass‐through chambers.

View screen – front Handles should be attached at each end of the front view screen mounting frame to facilitate installation and removal.

View screen – front A gasket manufactured of synthetic materials suitable to class III glovebox containment applications shall be installed so that when the front view screen is attached the glovebox can achieve gas‐tight containment.

View screen – rear Rear viewing screen should be sealed to the glovebox and will not be removed.

Gloveports Oval glove ports must be built into the front and rear view screens. Gloves must be securely attached to the ports in a manner that prevents the gloves from accidentally coming off during use. Gloves must be able to be replaced without breaking containment.

Gloveports – front Oval stainless steel glove ports (#<10) must be built into the front view screen spaced ergonomically at the correct across the front view screen. Final quantity and placement will be finalize through the design process.

Gloveports – rear Two (2ea) oval stainless steel glove ports must be built into the rear view screen spaced ergonomically at the correct horizontal distance across the rear view screen. Final placement to be determined through the design process.

Glove – material and size Each gloveport fitted with a single piece arm length glove, left and right hand, size 9.5 (glove and sleeve shall be made of one piece Hypalon material) shall be provided by the manufacturer.

Electrical ‐ interior The interior is illuminated by LED lighting mounted on the exterior of the glovebox for ease of maintenance and to prevent heat build‐up in the work area.

Electrical ‐ interior Four pairs of sealed “drop‐down” electrical 110v North American grounded standard three prong receptacles provided within the chamber work area evenly spaced across the rear of the glovebox. Each cord length shall drop‐down ~6” in the ceiling of work space at the rear of the glovebox (6” does not include length of outlet box). Outlets are to be equipped with individual weather‐proof covers.

Electrical – interior 110v Interior outlets should be wired on an independent circuit through a single main ON/OFF power switch on the control panel with a 15‐amp Ground Fault Current Interrupt (GFCI) protected circuit and utilize a separate 10’ molded, grounded standard three prong plug.

Electrical – interior 208v One interior 208v power outlet with weather‐ proof cover with a 10’ exterior cord 208v plug.

This outlet should be mounted in the bottom‐ right rear of the glovebox (as facing the glovebox).

Utilities Three ports for utilities located on the left rear (as facing the glovebox) approximately 12” above the work area floor.

Pass‐through chamber The glovebox shall be equipped with two (2) 24”x24” large pass through chambers. Each chamber shall be mounted at each end of the glovebox.

Pass‐through chamber Include two‐door pass‐through chamber that can decontaminated between uses.

Pass‐through chamber The interior of the pass‐through chamber must be constructed with smooth finishes that can be easily cleaned and decontaminated; with coved corners and radius bends; and sharp edges eliminated to reduce the potential for cuts and tears of gloves and operator safety.

Pass‐through chamber – view screen A non‐removable view screen mounted into the top each pass‐through chamber.

Pass‐through chamber ‐ filtration Include automatic HEPA purging to the filtration system with single HEPA supply and dual HEPA exhaust capabilities

Pass‐through chamber door opening – exterior Forward facing door opening

Pass‐through chamber door opening – interior Interior glovebox airlock door

Pass‐through chamber ‐ airlock doors Airlock doors use programmable logic controller (PLC) and be electro‐mechanically interlocked.

Control panel Digital and mechanical differential pressure gauges readily observable to the operator.

Control panel Low‐pressure alarm with audible and visual functions readily observable to the operator

Control panel Separate main and light on/off power switches with circuit breaker reset readily accessible to the operator.

Glovebox – airflow Airflow is maintained by an exhaust system exterior to the cabinet, which keeps the cabinet under negative pressure (minimum of 0.5 inches of water gauge.)

Secondary HEPA filtration system HEPA filter housings on glovebox must be leak‐ free and designed to allow certifiers to scan test filters to validate that they are leak free. Per the BMBL, Class III Biological Safety Cabinets require double HEPA filtration on all exhaust air, provisions must be made to check the integrity of each exhaust HEPA filter individually.

Secondary HEPA filtration system The interior of the plenums, fans and filters must be able to be decontaminated using a validated gaseous or vapor method.

Secondary HEPA filtration system – Construction Supply and exhaust filtration housings should be fabricated utilizing stainless steel including stainless steel valves. Assuming the filter housings are mounted above the glovebox, the filter housings must be removable to ensure the glovebox will fit through the 34” wide x 83” high mandoor.

Secondary HEPA filtration system – Filter capability

HEPA filter must remove to most penetrating particle size (MPPS) of 0.3µm with an efficiency of 99.97% or better. Manufacturer shall provide written documentation of filter design capability.

Secondary HEPA filtration system – Filter size HEPA filter size should be suitable for the glovebox size and use as described in this document.

Secondary HEPA filtration system – Supply air Supply air in to glovebox must be HEPA filtered.

Supply air must be provided in such a manner that prevents positive pressurization of the cabinet.

Secondary HEPA filtration system – Exhaust air Exhaust air must pass through two HEPA filters before discharge.

Secondary HEPA filtration system‐BI/BO All HEPA filters and housings must be equipped with bag‐in/bag‐out (BI/BO) capabilities. A bag‐in bag‐out enclosure housing for HEPA filters allows for the removal of the contaminated filter without worker exposure.

Secondary HEPA filtration system – Testing The filter housings should be leak tested using pressure decay test rate of rise test helium leak test to verify all housings meet applicable standards (no leak greater that 1X10‐7cc /sec with 1% test gas at 3 inches pressure Water Gauge).

Glovebox and filtration housing testing Manufacturer shall fully test glove box and filtration system prior to shipping and provide test data results to customer. The manufacturer must allow for customer representatives to attend factory testing at customer expense.

Glovebox and filtration housing testing – standards

Manufacturer tests shall include:

Pressure decay testing rate of rise test helium leak test electrical safety tests on all electrical circuits control panel tests of all control panel safety and electrical systems.

Glovebox stand ‐ construction Manufacturer shall fabricate the stand for the glovebox from stainless steel and rated for holding no less than 1,000 lbs. above the gross combined weight of the glovebox, pass‐through chambers, and filtration system housings.

Glovebox stand ‐ height The height of the glovebox work area floor to laboratory should be 36” for operator comfort.

Glovebox stand ‐ castors The glovebox will be mobile. Rotating, lockable castors manufactured of non‐porous materials securely mounted on each glovebox stand leg.

Castors should freely rotate 360°. When in the lock position the glovebox should not move. The height of the castors is included in the 36” working height.

Manuals – glovebox and components Manufacturer shall provide appropriate manuals and documentation in one hard copy (bound or appropriate size three‐ring binder and one portable document file (pdf) softcopy on two compact disks (not a ‘thumb drive’ or ‘memory stick’). All manuals shall be in written in American English (also called U.S. English). All measurements shall be provided in U.S. Standard Units and Metric Units. Photographs, figures, and tables may be incorporated as appropriate:

Product/Instruction manual

Installation manual

Troubleshoot manual

Maintenance manual with repair parts list and manufacturers.

Data plate A data plate listing at a minimum the manufacturer name, date of manufacturer, and manufacturer serial number (or a blank space for a customer serial number) shall be affixed near the control panel and easily visible from the front of the glovebox.

Shipping Manufacturer is required to ship the glovebox and component parts to customer location at Dugway, Utah. The manufacturer must contact the customer to coordinate delivery prior to shipping.

Warranty ‐ Glovebox 24 month or greater warranty on glovebox workmanship and parts.

Warranty – Component parts Original equipment manufacturer (OEM) warranties shall transfer to customer.

Manufacturer Procurement is directly with manufacturer or a manufacturer authorized retailer. Authorized retailer status will be verified by customer with manufacturer prior to contract selection. Non‐ authorized retailers will not be considered.

Manufacturing location Glovebox must be U.S. made. Manufacturer shall provide location where the glovebox primary components (glovebox, pass‐through chambers, filtration housing) will be manufactured, assembled, and factory testing performed.

Consumable spare parts Manufacture shall provide one complete spare set of all gaskets and consumable parts (except gloves and HEPA filters).

Chemicals used in glovebox For manufacturer reference. Chemical disinfectants and preservation chemicals commonly used in biologic containment will be used in the glovebox. Typical decontamination chemicals used are hydrogen peroxide and chlorine bleach diluted with water.