2. Producer and Manufacturer
HIGH PURITY ETHANOL
For Pharma, Medical & Critical Industrial Applications
PHARMACEUTICAL GRADE SOLVENTS
That exceed Global requirements
STERILE SOLVENTS & CUSTOM BLENDS
In Production Quantities for Demanding Markets
Pharma Solvents for Global Requirements
3. Our Purpose
Our purpose is to provide pharmaceutical grade process solvents in production
quantities that enable our clients to stay one step ahead of ever-increasing
global requirements.
Pharmco-Aaper is an FDA registered facility operating under all applicable
current good manufacturing practices (cGMP.)
Our references include an impressive array of U.S. and international companies!
Note: all pictures contained in this presentation are actual photos of our facilities and employees!
4. Sample List of Clients
PHARMACEUTICAL:
3M, Abbott, Amgen, Anchen, Astra-Zeneca, Aventis, Baxter, Bayer, Becton Dickinson, Biogen, Boehringer-Ingleheim,
Bristol Myers Squibb (BMS), Catalent, Cambrex Bioscience, Catalytica Pharmaceutical, Celltrion, Cenacor, Colorcon,
Cott, Covidien, EISAI, Eli Lilly, Genzyme,
Glaxo Smith Kline, Hoffmann La Roche, Hospira, Imclone, Johnson & Johnson Companies,
Midimmune, Merck, Novartis, Ortho-McNeil, Ortho-Pharma, Ortho-Biotech, Pfizer,
Polysciences, Precision Pharmaceutical, Purdue Pharma, Roche, Sanofi-Pastuer,
Sandoz, Schering Plough, Stiefel Labs, Sun Pharma, TEVA, Warner-Lambert, Wyeth.
Flavor & Fragrance:
Adams Extracts, Alan Flavors, Citroil, Firmenich, Fruterom, Givaudan, IFF, Kerry-Matertaste,
OSF Quest, Robertet, Sensient, Sovereign Flavors, Symrise, T.Hasegawa, Virginia Dare.
Specialty Chemical and Critical Industrial:
Acros, American Distilling, BASF, Cytec, Dupont, Honeywell, ISP, Monsanto, Noramco, Ophthalmic Innovations, P&G,
Phillip Morris, Sigma-Adrich, Stepan, Unilever.
Government, Educational and Medical Institutions:
CDC, DEA, DEP, EPA, FDA, Harvard, Institute for Genomic Research, Memorial Sloan Kettering,
MIT, NASA, National Institute of Health (NIH), New York University, UCLA – Medical, NYU,
Princeton, Scripps Research Institute, UMDNJ, Yale.
5. Our Parent Company
Our parent company (GFE) is the largest producer of
Ethanol in Canada.
GFE produces over 30 million gallons (114 million
liters) per year of high purity ethanol at our plant in
Chatham, Ontario, Canada.
Pharma Solvents for Global Requirements
6. Spotlight on Chatham
Our Chatham plant is our premier Ethanol facility producing the
highest quality analytical and pharmaceutical grade ethanol in the world.
NOTES:
1. Ability to expand beyond our capacity to meet global requirements.
2. Full testing of each railcar prior to shipment
Dedicated fleet of railcars
3. ISO9001:2008 compliant.
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4. FDA compliant.
5. Zero waste facility and Negative carbon footprint.
Pharma Solvents for Global Requirements
7. Chatham’s Unique Distillation System
Our Eight column distillation system gives us the ability to produce Ethanol to these quality levels.
Pharma Solvents for Global Requirements
8. Ethanol Products
1. Highest pharmaceutical and analytical grade quality in the world.
2. Comprehensive line of pure and denatured ethanol products including custom cuts,
blends and formulas.
3. Multi-compendial certified finished products – each lot! Minimum specs: USP/ACS
and Kosher.
Notes:
1. Complete ownership and control of quality
2. Full testing upon receipt and full compendial testing
for each packaged lot.
3. 0.22 micron filtered.
4. Produced from a renewable resource: corn.
5. Dedicated Railcars for transportation from producer to packaging site.
Pharma Solvents for Global Requirements
9. Pharmaceutical Grade Solvents
1. Full monograph testing of all raw material prior to receipt, during filling and final
product.
2. Custom blends and specifications.
3. Package options from pints to Iso-tainers and tank trucks.
Pharma Solvents for Global Requirements
10. Sterile Solvents and Custom Blends
1. Ethanol and related solvents from small package
to production quantities.
2. Custom specifications and blends.
3. Endotoxin free products / Gamma Irradiation for sterility.
4. Validation programs upon request.
5. Full compendial and sterility testing on each packaged lot.
Pharma Solvents for Global Requirements
11. Quality Products: Added Value to benefit you
1. Multi-compendial certification.
2. Custom specifications, blends and sterile products.
3. The highest quality ethanol in the world.
4. A comprehensive range of pure and denatured
ethanol products.
5. Fully tested finished product.
Pharma Solvents for Global Requirements
12. Quality Process: Resources to empower you
1. Dedicated manufacturing facilities offering security of supply and total control of
quality, from raw material to finished product.
2. Fully staffed on-site quality control labs at each facility and plant.
3. FDA registration for drug and medical device establishment / Organic, Kosher,
HACCP & cGMP operation: Total quality system under ISO registration.
Notes:
1. Rigorous internal auditing.
2. Robust change control systems and continuous
process improvement.
3. Separate Quality Control and Quality Assurance departments.
4. Finished goods warehouses throughout the U.S. and the world.
5. Environmentally compliant, zero-waste facilities.
6. Strategically located near the port of NY (U.S.) for ease of export.
Pharma Solvents for Global Requirements
13. Quality People: Ready to Assist you
Technical Support
1. Ethanol product selection; pure and denatured.
2. Custom solvent development and validation requirements.
3. High purity solvent selection.
4. Issuance of product samples and literature.
5. Assistance with regulatory compliance.
Pharma Solvents for Global Requirements
14. Business Continuity
Our three manufacturing and packing locations are integrated to support each other in the event of
any business interruption.
Brookfield, Connecticut
50,000 square foot facility
Shelbyville, Kentucky
30,000 square foot facility
Brampton, Ontario
25,000 square foot facility
Pharma Solvents for Global Requirements
15. Full Range of Production Capabilities
1. Stainless Steel Batching Tanks.
2. Class 10,000 Clean Room & cGMP White Room.
3. High speed filling lines.
4. Dedicated storage tanks.
5. Custom label printing department.
6. 0.22 micron filtering systems.
7. Packaging capabilities from pints to iso-tainers.
1.25 Million Gallons of Storage
Pharma Solvents for Global Requirements
16. Clean and White Rooms
We are the only ethanol producer or manufacturer in the Western Hemisphere that is FDA and ISO
registered with an on-site Class 10,000 Clean Room and a cGMP / Kosher / HACCP compliant White
Room.
Notes:
1. FDA registration for drug and medical device establishment.
2. Class 10,000 Clean Room and White Room facilities.
3. Organic, Kosher, HACCP & cGMP operations.
4. Capacity to expand.
5. Capacity for custom blends and products.
6. Validated room and validated process.
7. Operates as an integrated part of our total quality system.
8. Small package and drum capabilities.
9. Gamma Irradiated and Endotoxin Free Products.
Pharma Solvents for Global Requirements
17. QUALITY CONTROL LAB
1. Our on-site lab is equipped with state of the art instrumentation and adequately staffed
2. We analyze all raw material well beyond compendial requirements to insure our
understanding of the quality of our finished products.
3. We offer certificates of analysis on raw material as well as finished goods.
Pharma Solvents for Global Requirements
18. Spotlight on Improvement – ICP-MS Unit
ICP-MS INSTRUMENT
1. New USP standards in 2013.
2. Metals analysis for select solvents.
Pharma Solvents for Global Requirements
19. LABEL ROOM
1. In house printing capabilities.
2. Custom labeling.
3. Fully integrated and under the supervision of our quality system.
Pharma Solvents for Global Requirements
20. Multiple Packaging Options
Our extensive packaging options allow for a finished product scale up range from pints to tank trucks
and iso-tainers.
Pints: Poly and Glass
500ml: Glass and Poly
1 Liter: Glass and Poly
Gallons: Poly
4 x 4 Liter: Glass
2.5 Liter: Glass and Poly
5 Gallon Shelf Sitters, cubes, poly & metal
30 Gallon Drum: Poly
55 Gallon new Metal lined-Drum
55 Gallon new Poly Drum
55 Gallon Drum: UV protected
Tanks: SS Trucks and Iso-tainers
Other options: please inquire
Pharma Solvents for Global Requirements
21. Multi-Compendial
Product Overview (EP/BP/JP/USP/ACS/FCC…)
1. Ethanol (Pure and Denatured),
Kosher, Organic, KFP, other
2. Ethanol Blends and cuts Other common USP & ACS Grade Solvents used in API
production handled through the same dedicated, regulated
3. Acetone systems:
4. Benzyl Alcohol
1. Acetonitrile
5. Dichloromethane
2. n-Butyl Alcohol
6. DEP 3. Chloroform
7. Ethyl Acetate 4. DMF
8. Ethyl Ether 5. Ethylene Glycol
9. Glycerin 6. Heptane
7. Hexane
10. IPA (99%, 70% and various cuts)
8. MEK
11. Methanol 9. MIBK
12. n-Propyl Alcohol 10. MTBE
13. Propylene Glycol (PG) 11. Pentane
14. WATER: USP, EP, Distilled, WFI 12. Petroleum Ether
13. Tetrahydrofuran (THF)
15. Custom Solvent Blends 14. Toluene
16. Sterile Solvents 15. TMP (Trimethyl Pentane, 2,2,4)
Please Inquire for other solvents!
Pharma Solvents for Global Requirements
