APPENDIX A - CLEANROOMS
Terms defined in the General Terms and Conditions of Sale to which this Appendix A is attached (the “Terms”) have the same meaning in Appendix A, unless otherwise specified herein.
1. Standards and Certifications:
a. NAPRA compliant deliverables as addressed in this quote are designed in compliance with current published NAPRA rules and regulations. See Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations - Revision B on Napra.ca.
b. Further changes in ROHS, NSF, Health Canada, NAPRA, USP, or other relevant rules, standards, or regulations, occurring after the quotation has been issued will be the responsibility of the Buyer. Further associated cost in order to bring the current design up to new standards will not be assumed by the Supplier.
2. Buyer Responsibilities:
a. Buyer’s electrician is responsible for wiring power to any main junction box and receptacles, sink, pass throughs, and any other electrical connections. Electrical panel/breakers are to be provided by the Buyer.
b. Buyer is responsible for feeding HVAC supply to the space above a cleanroom or directly to fan filter modules.
c. Buyer is responsible for any structural or seismic bracing to existing building and structure.
d. Any wiring and plenum tubing provided must be plenum rated.
e. Mechanical services to be provided by the Buyer are to be accessible for the mechanical equipment to be mounted as stated in the quotation. All services to be terminated by the Buyer with shut off valves.
f. Hot water, chilled glycol (water), hot glycol lines and steam lines (if required) are to be brought to the job site by the Buyer.
g. Water for humidification purposes, drain for humidifier and coil condensate (if required) are to be provided by the Buyer.
h. Condensate drain (if required) is to be brought within 5 feet of HVAC equipment by the Buyer.
i. Connections from the supply/return/exhaust ductwork to the Supplier’s ceiling/wall returns are the responsibility of the Buyer.
j. If applicable, balancing dampers must be located on all supply duct drops to the HEPA/ULPA modules and from all returns to the return air ductwork.
k. Buyer is responsible for exhausting air from a negative room to place the room under negative relative static air pressure through the use of a dedicated exhaust blower.
3. Installation Requirements:
a. The facility’s floor is assumed to be reasonably level. If the walls cannot be placed correctly due to variations in the existing floor, then additional shimming and possibly trim may be required to close gaps. Additional charges may apply depending on the amount of correction required.
b. A minimum available ceiling height is required as stated in the quotation, otherwise additional fees/work will be required.
c. No job site preparation or storage is included. We assume the job site will be ready to receive all the components listed in the quotation and that a loading dock with necessary off-loading equipment is readily available. If the loading dock is remote from the job site, there may be additional costs involved to transport the goods to the job site.
d. All items required by the Supplier installation technicians are to be located on the job site in advance of the scheduled installation date as confirmed by the Supplier. Such delays will result in charges to the Buyer for the additional time, accommodations, travel, and any other additional expenses required to extend the installation period.
4. Specific Exclusions (including, but not limited to):
a. Plumbing, flooring, HVAC, electrical wiring and fire protection are the responsibility of the Buyer.
b. Any Unistrut or threaded rod is to be supplied and installed by others (i.e. not by the Supplier).
c. Certification where required is by others (i.e. not by the Supplier).
d. Any Work not specifically set out in this quotation is the responsibility of the Buyer. The Supplier is not responsible for performing any Work as it relates equipment provided by others.
e. Renovations/demolition necessary to prepare the job site are the responsibility of the Buyer.
f. Roof reinforcing, cuts or sealing are the responsibility of the Buyer.
g. Emergency power and all associated wiring and devices are the responsibility of the Buyer.
h. Permits, fees and necessary inspections are the responsibility of the Buyer.
i. Preparation of outside pads for air handling units is the responsibility of the Buyer.
j. Decorative features which might be desired to hide roof or ground level mounted HVAC or other equipment are the responsibility of the Buyer.
k. Any cuts in concrete slabs are the responsibility of the Buyer.
l. Asbestos removal is the responsibility of the Buyer.
m. Job site telephones and communication links are the responsibility of the Buyer.
n. DMAC (Data Management Acquisition & Control) is not included.
o. IQ/OQ validation/documentation is not included unless otherwise stated in the Order.
p. Temperature and humidity controls at the job site are the responsibility of the Buyer unless otherwise stated in the Order.
q. ESD and ionization devices/equipment and other special surface finishes are not included unless otherwise stated in the Order.
r. Room pressure balancing is the responsibility of the Buyer.