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The following is a sample of some of the projects that GL Engineering has undertaken.
Wyeth Global Engineering, Wyeth Ireland. Vial washing, depyrogenation /
sterilization, filling, 3 X 440sqft lyophilizers, lyo loading system,
vial capping, vial ID, vial inspection and tray loading. Design /
Procurement / Vendor Management / FAT / Installation / Commissioning.
PSGA, Gurabo, Puerto Rico (Joint Venture With Advanced Barrier
Concepts). Vial washing, depyrogenation / sterilization, filling, 3 X
220sqft lyophilizers, lyo loading system, vial capping, vial ID and tray
loading. Design / Procurement / Manufacture Management / FAT /
Installation / Commissioning / SAT.
Amersham Pharmaceuticals, Amersham, UK. Sterile isolated filling and
terminal sterilization of radioactive nuclides, Design / Manufacture /
FAT / Installation / Commissioning / SAT.
Wyeth B60, Pearl River, NY. Feasibility study for a vial washing,
depyrogenation / sterilization, filling, 2 X 330sqft lyophilizers, lyo
loading system, vial capping & vial inspection.
Inhale Therapeutics, San Carlos, CA. Spray dryer discharge & containment
system. Design / Procurement / Vendor Management / FAT.
Pfizer, Terra Haute, IN. Spray dryer discharge & containment system.
Design / Procurement / Vendor Management / FAT.
B20 Wyeth, Marietta, PA. Feasibility study for the addition of 2X360sqft
lyophilizers and auto-loading system to an existing vial filling and
inspection line.
Organon, Oss, The Netherlands. Sterile component handling for an
isolated vial filling line. Design / Manufacture / FAT / Installation /
Commissioning / SAT.
Wyeth Global Engineering, Wyeth Ireland. Technology evaluation for a
barrier / isolator syringe filling & inspection line.
Parke-Davis, Ann Arbor, MI. Feasibility study for a barrier / isolator
Phase III Clinical and production start up facility for aseptic / potent
products.
Wyeth B20, Marietta, PA. Vial washing, depyrogenation / sterilization,
filling, vial capping, vial inspection and tray loading. Design /
Procurement / Vendor Management / FAT / Installation / Commissioning /
SAT
Wyeth B32, Marietta, PA. Vial washing, depyrogenation / sterilization,
filling, vial capping, vial inspection and tray loading. FAT
Medeva, Liverpool, England. Sterile component handling for an isolated
syringe filling line. Design / Manufacture / FAT / Installation /
Commissioning / SAT / IQ / OQ.
Wyeth B112, Pearl River, NY. Hypack syringe denesting, inspection,
labeling and renesting line. Design / Procurement / Vendor Management /
FAT / Installation / Commissioning.
Medefil, Chicago, IL. Compliance audit and corrective actions.
Wyeth B20, Marietta, PA. Diluent filling and pouching line. Design /
Procurement / Vendor Management.
Wyeth B60, Pearl River, NY. Filling line upgrades.
MedImmune, Philadelphia, PA. Syringe processing - Filling, inspection,
labeling and packaging line. Design / Procurement / Vendor Management /
FAT / Installation / Commissioning / SAT / IQ / OQ / PQ / Production
Assistance.
Wyeth, Marietta, PA. Egg harvesting project. Design / Procurement /
Manufacture Management / FAT.
Upjohn, Kalamazoo, MI. Isolated clinical & start up production filling
system for potent compounds. Design / Manufacture / FAT / Installation /
Commissioning.
Wyeth Global Engineering, Collegeville, PA. New concept sterile delivery
device evaluation. Feasibility study for a barrier / isolator Phase II &
III Clinical facilities and production start up manufacturing.
Wyeth Pharmaceuticals Company, Guayama, Puerto Rico. High volume oral
dosage filling and packaging line. Design / Procurement / Vendor
Management / FAT / Installation / SAT / Commissioning / IQ /OQ /PQ
Support.
Wyeth Pharmaceuticals Company, Guayama, Puerto Rico. High & intermediate
volume oral dosage packaging lines (5 total) upgrades and retrofits.
Design / Procurement / Vendor Management / FAT / Installation / SAT /
Commissioning / IQ / OQ /PQ Support.
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