HOT AIR OVEN EQUIPMENT PERFORMANCE SPECIFICATIONS

Equipment Description
The cGMP Class 100 Dry Heat Sterilizer [Hot Air Oven (HAO)] shall be designed for highly effective
depyrogenation of hard goods used in pharmaceutical applications.

The area available for this equipment is limited to 57” deep by 67” wide (including access for
maintenance); therefore please provide the largest size chamber based on this floor space restriction,
preferably at least 38” in width, 51” in height, and 35” in depth or larger. Include all utility requirements
and an AutoCaD layout in proposal.

Equipment Design
1. Equipment shall be designed and manufactured to conform with the requirements of current Good
Manufacturing Practices (FDA 21CFR part 210/211) 14644 - 1 (Part 1) Class 5, for Classification
of Air Cleanliness (former Class 100 according to US Federal Standard 209 E) as well as ISO
14644 - 2 (Part 2) for Specification for Testing and Monitoring to prove continued compliance
with ISO 14644-1.
2. Process batch data shall be recorded /dumped as paper hard-copies to a chart recorder and/or
printer. (Process batches are validated, approved and accepted only by means of paper hard-copy
evidence.)
3. The HAO is equipped with two vertical sliding doors, designed for pass-through operations.

Option: Quote cost for two hinged doors instead of vertical sliding doors.

4. The chamber and all interior components including fan, fan shaft and heater conjunction box, shall
be constructed of AISI 316L stainless steel. The chamber shall be finished to a 2B mill finish (RA
value: ≤ 0.6 µm).
5. ISO Class 5 (Class 100) conditions are required throughout the cycle, including heating-up and
cooling, with a minimum exposure temperature of 250°C without need for ramping during heating
or cooling.
6. The fully welded chamber shall be also welded to the outside cladding. No cover plates are to be
used to hide sheet connections in the door frame. No screws or rivets are allowed for the chamber
construction.
7. The HEPA filters shall be installed on a filter suspension system which provides absolute particle
sealing during heating and cooling, maintaining ISO Class 5/Class 100 during the entire cycle.
Easy HEPA filters access for replacement is required and suitable for DOP testing in place.
8. Internal air distribution plates and cart rails shall be removable for easy cleaning.
9. Double door gaskets constructed of heat resistant silicone are required to minimize risk of leakage.
10. The exterior shall be of AISI 304 stainless steel, with 180-240 grit polish.
11. Doors shall be locked and unlocked automatically by means of the process controller ensuring
correct door operation. Sterile and non-sterile door must not be operable at the same time. In case
of a power supply interruption, the doors on both sides will be locked closed. The electro-
mechanical interlocks prevent improper or accidental door operation even during power loss. The
electro-mechanical door interlock device shall be serviceable from the maintenance area. All
doors shall lock automatically upon initiation of a cycle. Cycle approval must be granted before
the sterile side door can be opened.
12. User operator panel will indicate the door position on sterile side.

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 HOT AIR OVEN EQUIPMENT PERFORMANCE SPECIFICATIONS

13. For easy validation of the HAO a 1.5” Aseptic IDF port shall be placed in the front of the door on
the loading side. (This port is applicable for particle measuring and for temperature measuring).
14. For challenging of the chamber filters a 1” BSP port is required on the top of the sterilizer
15. Temperature readout and printout shall be provided in 0.1C increments.
16. The HAO will automatically maintain a chamber pressure between the higher pressure on the
sterile side, and the lower pressure on the non-sterile side. A pressure controller will automatically
control the amount of the replacement air supplied by a fan, providing a constant over-pressure
independent of the position of the exhaust damper, the condition of the sterile filter, and any leaks.
A 99.997% HEPA filter is required in the inlet air, providing clean substitution air for the
chamber. The filter must be capable of being DOP tested and checked by the Owner. The over-
pressure shall be adjustable between 20-70 Pascal and indicated so on the pressure differential
gauge 0-100 Pascal.
17. The HEPA filter shall be 12” (292 mm) thick to allow for maximum air flow through the filter
with minimum pressure drop.
18. An inlet air pre-filter is required to prolong the lifetime of the HEPA filter.
19. A servo-controlled exhaust damper is required to facilitate drying during the first part of the cycle
and will open during the cooling cycle, if air cooling is selected. In this case, the damper shall
close automatically after cooling.
20. The exhaust air shall be filtered through a heat and water resistant HEPA filter providing a
filtration of 99.997% of all particles above 0.3 micron size and preventing particles from migrating
back into the chamber. The exhaust filter shall be 12” (292 mm) thick to allow for maximum air
flow through the filter with minimum pressure drop.
21. The filter shall be capable of DOP testing in both directions without having to disconnect the
exhaust ducting.
22. The electrical heating elements shall be constructed of AISI 321 or Incoloy 800 heat resistant
stainless steel to extend lifetime. The heater shall be water and airtight and easy to keep clean.

The following control capabilities to be provided:

1. The HAO shall have automatic control of all the HAO functions.
2. The Operator Interface Panel (HMI) shall display an equipment graphic displaying device status
and process parameters for operator reference during processing, recipe generation or selection and
setup/maintenance.
3. Three levels of security shall be provided for the HMI or PLC (each level shall be provided with
the functionality noted).
4. The operator interface shall be mounted on the front fascia (on the loading side of the HAO).
(touch screen panel with color display).
5. The unload side of the double door HAO shall be equipped with a digital operator interface panel
for door operation and cycle progress monitoring. (touch screen panel with color display)
6. A safety thermostat shall be provided that protects the HAO against uncontrolled over-heating.
The thermostat shall be hard wired and not a part of the PLC temperature control system. The
safety thermostat is also connected to an alarm.
7. A minimum of 99 programmable cycles shall be available with a wide range of settable
parameters, which provides for a high degree of functionality and allow great freedom in designing
cycles for various products.
8. Provide Printer/Recorder options.
9. Magnehelic pressure gauge for the indication of chamber pressure (0-100 Pascal).
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 HOT AIR OVEN EQUIPMENT PERFORMANCE SPECIFICATIONS

10. Magnehelic pressure gauge for the indication of pressure drop across the HEPA filters.
11. Include an emergency switch (as a push button switch) that will stop the cycle, but not open the
doors.
12. Options: Quote cost for the following:

a) Forced air cooling effected by means of HEPA filtered substitution air.

b) Water cooling arrangement.

c) Load probes

d) Printer for control system.

e) Multipoint recorder for process reports.

f) Racks and Transfer trolleys.

Equipment Construction
1. Electrical panel shall have UL approval and be stamped accordingly.
2. Materials of construction
a. Contact surfaces: 316L stainless steel or virgin autoclaveable Teflon
b. Seals and gaskets: FDA grade, autoclaveable viton or silicone
c. Non-contact surfaces: minimum 304 stainless steel, or Delrin AFWeld Treatment
d. Internal surfaces to be finished as needed to meet the requirements of the process, cGMP
requirements and current industry standards
e. All external stainless steel finishes to be minimum #4 polish
3. Bioseal seal for the unloading side is required. The bioseal provides a cross-contamination barrier
to isolate the mechanical room from a clean room on the unload side of the HAO. The bioseal
shall be constructed with a stainless steel flange welded to the HAO chamber, with pre-drilled and
taped holes on which a flexible silicon rubber bio-seal will be sandwiched between a 316 stainless
steel fascia panel which will be fitted to the flange to provide a sealed wall system.

Option: Quote cost for an air differential shield instead of the bioseal.

4. The exterior of the chamber jacket shall be covered with chloride-free insulation. The insulation
shall be encased within a sturdy stainless steel and sealed for water tightness.
5. The outer surface temperature is kept to a minimum, below 40°C on greater surfaces at an
operating temperature of 250°C.
6. The frame shall have adjustable feet (AISI 304 stainless steel) at the base of the frame to allow for
leveling during installation.
7. All machine components to be accessible for easy service and cleaning.
8. HAO to operate on 208/230/480 60Hertz (phase to be determined) standard USA electrical service

Weldments
1. Where feasible, welds subject to high temperatures to be passivated.
2. In critical areas, where accessible, welds to be ground and polished.
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 HOT AIR OVEN EQUIPMENT PERFORMANCE SPECIFICATIONS

3. Where technically feasible, in critical areas, continuous welds to be used.

Option: Quote cost for providing weld documentation in accordance with ASME BPE and
include all machine orbital welds.

Testing and Certification (Performance Acceptance Criteria)

1. All equipment instrumentation shall be calibrated prior to commencing the Vendor Internal
Testing which should be completely by the vendor in advance of the FAT.
2. Factory Acceptance Test Protocols required for Owner review at least two weeks prior to schedule
FAT.
3. Minimum documentation includes:
 Piping and Instrumentation Diagram
 Installation Drawings
 Electrical Diagrams
 Control System Documentation
 Software Source Code Listing
 Installation Manual
 Operational Manual
 Mechanical Component Parts List & Data Sheets
 Electrical Component Parts List & Data Sheets
 Mechanical Component Catalog Cut Sheets
 Electrical Component Catalog Cut Sheets
 Material Certificates
 Pressure Vessel Certificates
 Recommended Maintenance Schedule
 Spare Parts Listing
 Assembly drawings
 Trouble Shooting Information
 Hard and soft copies of all documents to be provided

Option: Quote cost for providing proof of compliance to surface finish specifications and
welding log.

4. Factory Acceptance Testing to be observed by Owner’s personnel prior to shipment with final
acceptance determined by successful execution validation at Owner’s site. Available for review at
the FAT and included with delivery, vendor to supply Owner with complete information package.
This package to include, at a minimum, material certificates, calibration certificates for process
instruments, correct alarm activation and other information as required by Owner’s validation
group. If the options for providing proof of compliance to surface finish specifications, welding
log, and weld documentation that includes all machine orbital welds are accepted, this information
must also be provided.

Equipment Delivery
1. The number of days following notification of award that the equipment will be received in
Owner’s facility must be stated. This will be considered in bid award.
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 HOT AIR OVEN EQUIPMENT PERFORMANCE SPECIFICATIONS

2. Crating to be per overseas crating procedure.

3. Responsibilities of the equipment supplier include but are not limited to delivery, uncrating,
assembly, installation in place, start-up and training. The Construction Manager/General
Contractor will make final utility connections only.
4. The facility in which the HAO will be located is on the sixth floor of the newly constructed
College of Pharmacy Building. Delivery will be to the Basement level loading dock. The following
are the two options for transportation to the sixth floor:
a. Freight elevator: cab size 5’-10” W x 7’-10” D, capacity 4000 lbs., and door opening
of 4’-0” W X 7’-0” H.
b. Crane lift provided by Construction Manager/General Contractor with opening in sixth
floor of 10’-8” W x 9’-3” H.
5. Supplier must include dimensions and weight of HAO to be transported to sixth floor and if crane
lift or elevator is required.

Start-Up Service
Start-up service includes inspection of the equipment and installation, operating and adjustment of the
HAO, testing the operation, and training of the Owner’s operating and maintenance personnel.

Warranty
Equipment to be warranted, from date of delivery, against any and all defects resulting from a fault in
manufacturing or a fault in materials used, for a period of one (1) year.

Service
State how and from where service will be provided for the hot air oven.
The University requires 48 hours or less response time to Owner’s facility following receipt of service call
for the hot air oven. Please indicate if service can be provided meeting this requirement.
State the cost of a preventative maintenance/service agreement for the hot air oven after the warranty
period for the following time periods:
1. Year 1
2. Year 2
3. Year 3
4. Year 4
5. Year 5

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