Generic Cleanroom Construction Checklist Category Item General 1 2 3 4 5 Establish regular meeting schedule for overall project control and guidance Get final approved drawings for space Establish regular meeting schedule with Construction Manager for construction phase Get final approval for construction costs Obtain required approvals (building / town permits) 1 2 3 4 5 6 7 8 9 10 construct demising wall Back up Generator close warehouse pass-‐thru doors paint / patch general repairs (if required) reconfigure cubicles exterior signage interior signage Business park signage Visitors signs 11 12 13 Alarm system / security Establish a construction hold area for materials and parts delivery outside the cleanroom space for staging. Re-‐label parking spaces in lot 14 Gas line for generator/clean rooms. 1 2 3 4 5 6 7 8 9 10 Clean room construction DEMOLITION OF RX SPACE Primary Engineering controls (Hoods) Prep Area stools Clean room carts Clean room stools Stainless Steel Carts Prep Area fixtures Carts (Metro ™ or Similar ) Rubbermaid ™ (bins etc.) 11 12 13 14 15 16 17 18 19 20 21 Forms and labels (if changes are made/needed) Personal Protective Equipment Cleaning equipment & supplies Drug Inventory Compounding supplies Pharmacy required equipment list Refrigerator (Rx) Ordering of automated Compounders Ordering of Zebra Printers Individual UPS for clean room and other critical components Bloc-‐freezer 1 2 3 4 5 6 7 8 9 Datacom Circuit Datacom Equipment Voice telecom Equipment Cabling Move of existing service from 11-‐H to 11-‐B Computer Equipment printers / faxes Complete computer/tele closet in warehouse set-‐up of VMX, phones, & system passwords for all new employees 10 Battery back-‐ups General construction Pharmacy / Compounding Area Information Systems / Technology Vendor Generic Cleanroom Construction Checklist Office Space 1 2 3 4 5 6 7 8 9 10 12 13 14 15 16 Office Furniture (General / waiting areas) Office Furniture (office) Office Furniture (Office) Office Furniture (Filing cabinets) Office Furniture (break room) Office Furniture (Conference Room) Conference room (media equipment) Office Furniture (side chairs) Office Furniture (task chairs) Office Furniture Break room equipment Office Supplies Business machines (copier, fax, postage) Artwork / wall hangings Legal postings 1 2 3 4 5 6 7 Generator Fixtures & Furniture Tools & equipment Warehouse or storeroom racking / shelving Fork lift or Walk behind straddle lift if needed Walk-‐in Refrigerator Loading Dock Plate 1 2 3 FDA application DEA certificate CDS application 4 5 BOP application/ renovation package Weights & Measures Inspection 6 Certification of clean room environments 1 2 3 4 5 6 7 8 9 10 Finalize staffing model Extend "in-‐house" offers Re-‐run ads? Re post with recruiters? Schedule phone interviews RPh's Schedule phone interviews techs Check references / OIG / License status In-‐person interviews Drug screens Offer letters 11 12 13 14 Training &Orientation materials Schedule training & Orientation Schedule media fills (x3) Job Descriptions written & approved 1 2 Critical failure & disaster plan for facility Emergency supplies Warehouse Legal / Regulatory Human resources Misc. Items Generic Cleanroom Construction Checklist Primary Responsibility Status Completion date Lead time needed Notes / comments 6 weeks for generator if required area preparation -‐once demolition is complete 2-‐3 weeks 2-‐3 weeks 2 weeks 1 week area out side cleanrooms signage changes if required signage changes if required signage changes if required Approved design required Must contact current vendor for space to remove their equipment. MUST PLAN FOR ANY CRITICAL FAILURES IN ALARMS AND ENTRY SYSTEM! Project to be done in 2 phases. Perimeter first, then cleanrooms after their completion. The generator & clean room air handler may require gas lines, this element should be included in the plumbing scope of work. Final delivery date of the components are critical. 1 week check with vendor 2 weeks 3 weeks 2 weeks 4 weeks 3 weeks 2 weeks 2 weeks 2 weeks 4-‐5 weeks 2 weeks 4 weeks na 4-‐6 weeks May re-‐use existing equipment to allow data entry compounding rooms, ante room, prep room racking, Proofs required prior to order (need at least a mock-‐up prior to filing with BOP) should standardize format consistent with ISMP standards (for compounding and OSHA regs.) incl eye wash stations Establish accounts for new distributor if required. BOP mandated equipt. if needed we must standardize on 4" wide label 2-‐4 weeks If needed for freezing shipping ice-‐blocks 2 weeks 2 weeks Must check Spec, alarm should be included on back-‐up or use cellular. Door locks an building access needed to be accounted for. Fail safe system to allow for entry in case of total power outage. Generic Cleanroom Construction Checklist for waiting area, and misc. (lobby table, book cases, plants, etc.) 2-‐3 weeks Table, chairs, telephones, Media boards Projector or other AV equipment? Lobby, reception, pvt offices 2 weeks Fridge, Microwave, dishwasher ?, etc. opening order + working stock need to coordinate full install once front offices are done. 6-‐8 weeks 2 weeks 6 weeks 1 week Minimum wage, workers comp. etc. to be installed in office area if needed commercial type for racking, packing / staging area basic hand tools lift preferred due to warehouse configuration & lay-‐out must coordinate with electrician for hook-‐up & final install IF Required…. Need spec! 6 weeks 4 weeks 30 day lead time to schedule inspection if needed if required if required varies upon availability of field techs 6 wks prior to start 4 wks prior to start 6 wks prior to start 6 wks prior to start 4 wks prior to start 4 wks prior to start 4 wks prior to start 4 wks prior to start 2-‐3 wks prior to start 2-‐3 wks prior to start 2 weeks prior to start 2-‐3 wks prior to start 2-‐3 wks prior to start Fix FT PT and Per diem numbers. ID of PIC. Proper protocol must be maintained do we have enough in pool to select a full staff from? REQUIRED REQUIRED REQUIRED new employee documents, driver tests, etc. need to be assembled and copied REQUIRED REQUIRED for disaster plan (flashlights etc.)