Download presentation
Presentation is loading. Please wait.
Published bySharon Hollingshead Modified over 9 years ago
3
Manufacturing More Than Pharmaceuticals-The Chao Center
4
Manufacturing Facility
5
Dr. Allen and Lee-Hwa Chao
6
From a Shell
7
To A Clean Corridor
8
Non cGMP Pilot Lab
9
Analytical /Formulation Laboratory
10
Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing
11
Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives
12
Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training
13
Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training Summer Internships (2) The Chao Center Internship Johnson & Johnson Internship Graduate Fellowships (1) Clerkships (2) High School Work Study (1) Manufacturing — cGMP Manufacturing of both clinical and commercial product
14
Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training Summer Internships (2) The Chao Center Internship Johnson & Johnson Internship Graduate Fellowships (1) Clerkships (2) High School Work Study (1)
15
Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product
16
Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry
17
Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry Faculty and Research Use — Mutually Beneficial Access to a cGMP Facility
18
Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry Faculty and Research Use — Mutually Beneficial Access to a cGMP Facility Create a Positive Impact on the Local and State Economy
19
-itis (Innovation) Facility Created a Portable Degowning Room Purchased an Off the Shelf Portable Clean Room (positive pressure) Added Casters for Portability Turned the HEPA Filters Upside Down (negative pressure) Qualified the System Developed a Cross Contamination Filter Identified Need Designed Device to Adapt to Differential Pressure Sensor and Sterile Filter Design Filter Removal and Addition Pole Applied for Provisional Patent
20
-itis (Innovation) Designed Drop Down Conduit for Laboratory Determined Design Limits Electrical Cords off Lab Bench-Safety and Space Limits Initial Cost and Allows Expansion of Services Allows Conduit to be Adapted for: Additional Snorkels to Remove Gases Additional Electrical Outlets with Different Voltages Additional Computer Outlets
21
cGMP Documentation Over 150 Standard Operating Procedures
22
cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs)
23
cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files
24
cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages
25
cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages
26
Center Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages 3 Performance Qualification (PQ) Packages
27
Center Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages 3 Performance Qualification (PQ) Packages Over 60 designated logbooks
28
cGMP Documentation Over 17,000 pages of Documentation
29
cGMP Documentation Over 17,000 pages of Documentation Placed end-to-end, documentation would cover the distance from The Chao Center to the School of Pharmacy and most of the way back
30
Lilly Contract Signing at the Dedication for Seromycin
31
Pharmaceutical Development Pre-Formulation Formulation Development and Pilot Lab Analytical Methods and Validation Studies Test of Raw Materials for Manufacturing Test Finished Product Develop and Validate Analytical Methods Stability Testing and ICH Stability Storage Stability Software Stability Chambers Regulatory Services
32
Manufacturing Tablets
33
Manufacturing Tablets Capsules
34
Manufacturing Tablets Capsules Semi-solids
35
Manufacturing Tablets Capsules Semi-solids Syrups
36
Manufacturing Tablets Capsules Semi-solids Syrups Suspensions
37
Manufacturing Tablets Capsules Semi-solids Syrups Suspensions Over-encapsulation (Blinding Studies)
38
Manufacturing and Analytical Equipment Zanasi Encapsulator Tooling Manesty Betapress (B-Tooling and D-Tooling) Kalish Bottle Capper Kalish Bottle Washer Tote Blender Gruenberg Oven Loma Metal Detector Sade-P2 Weigher / Sorter
39
Manufacturing and Analytical Equipment Enercon Induction Sealer Key Tablet Deduster / Capsule Polisher Agilent UV/Vis Spectrophotometer Agilent 1100 HPLC’s (2) Varian Dissolution Bath Agilent GC/Mass Spectrophotometer Compulab Tablet Coater Fluid-Air Fluid-Bed Dryer
40
Hands Across the Campus School of Pharmacy/Chao Center Integrating Education between Pharmacy and The Chao Center Support School of Pharmacy Functions Krannert-ECE Project Improve material receiving/handling processes Investigate automating warehouse temperature and humidity mapping procedure Birck Nanotechnology cGMP Initiative
41
Hands Across the Campus Civil Engineering 489 Course Project Students to design rotary oxidizer kiln and associated support facilities that theoretically will be located at The Chao Center
42
Partnerships/Relationships Pharmaceutical Companies Eli Lilly and Company Abbott Laboratories Johnson & Johnson Large, Medium and Small Pharma International Relationships AION-Australia Hisun Pharmaceuticals-China Kazakhstan-Ministry of Health Mahidol University-Bangkok, Thailand
43
Pharmaceutical Expertise 5 out of 17 Employees with over 80 years of Combined Pharmaceutical Industry Experience Experience in Writing CMC Sections for NDA’s, IND’s, ANDA’s and NADA’s Regulatory Knowledge Regarding Inspections, Submissions and Facilities Development and Manufacturing Experience in Nasals, Tablets, Capsules, Suspensions, Semi- solids, Lyophilization, and Injectables Integral Part of Development of Zidovudine, Exosurf, Lamictal, Lotemax, and Xigris
44
Manufacturing More Than Pharmaceuticals Education and the Training of Students Innovation Hands Across the Campus Program Faculty Research that is Mutually Beneficial Internationally Known and Recognized Supporting University, Pharmacy and Purdue Research Foundation Initiatives Entrepreneurial Positive Impact on the State of Indiana Economy
45
Training Segment-Flying Insect Light Traps Clean traps and replace glue- boards in sconce light traps Corridor 123 Corridor 128 Clean trap and empty catch drawer in vertical light traps Room 133 Room 134 Replace bulbs annually, in spring
Similar presentations
© 2024 SlidePlayer.com Inc.
All rights reserved.