PRFC Inc.

(Established in 1986)

7230 Lyons PO Box 944

Morton Grove, IL 60053 USA

Ph: 847-470-9767 Fax 847-967-8004

New office to serve the West Coast >>> Western Div Office Ph 775-828-7454

Fax 775-828-0641

Email Contact: PRFCGlen@aol.com

Pharmaceutical Resources for Compliance

Experienced in all facets of the pharmaceutical industry.

PRFC CAD SERVICES & 3D DIGITIZING CAD DRAFTING FOR AS LOW AS $150/Sheet

(Clink on Hyperlink for details)

We will support all of your validation needs

· Facility, HVAC, clean room design and qualification

· Bulk Pharmaceutical Chemical Process

· Biotechnology

· Computer Hardware & Software qualification

· Parenteral & Injectible processing experience

· Filling & Packaging

· Laboratory equipment qualification

· Calibration Instruments and Equipment Rentals (Kaye Data-loggers

· Design review for cGMP, cGLP & ISO9001 compliance

· Master Plan Development

· SOP Development

· Protocol preparation & execution

· Quality System Development

· cGPM & cGLP compliance audits

· Consent Decree response teams

Global Coverage with the PRFC Inc. Advantage

f ABBOTT Labs (North Chicago, IL)

f ALP INC. (Woodstock IL)

f ALZA INC. (Vacaville, CA)

f BAXTER (Round Lake, IL)

f GLAXO (Toronto ONT. Canada)

f GENENTECH (San Francisco, CA)

f GENZYME INC (Boston, MA)

f PATHOGENESIS INC (Seattle, WA)

f CENTEON (Kankakee, IL)

Achieving compliance & anticipating tomorrow’s needs today.

Facility, HVAC, clean room design and qualification

Ä Class 100 to 100,000 zones

Ä Aseptic Suites

Ä Laboratories

Ä Environmental Rooms

Ä Containment Areas

Ä Aseptic Filling/processing

Ä Laminar Flow Hoods

Ä Biosafety Cabinets

Ä Environmental Monitoring

Parenteral & Injectible processing experience:

Depyrogenation Ovens/tunnels

Ethylene Oxide Sterilization

Terminal Sterilization

Radiation Sterilization

Lyophilizer

Sterile Filtration

Inspection Stations

Stopper Washing /sterilizing

Media Fills

Stoppering /crimping

PRFC Inc. staff have participated as the "Independent Expert" certification team,

required by FDA consent decree

Expertise in pharmaceutical process & equipment validation.

· Bulk Pharmaceutical Chemical

+ Reactors, Crystallizers

+ Centrifuges, Filtration

+ Distillation Columns, Tank Farms, Solvent Recovery

+ Material Handling: Extruders, screw feeders, conveyors

+ Clean & Plant utilities: Air, Water, Steam

+ Cleaning Validation

· Biotechnology

+ Master Cell Bank, Inoculation

+ Media & Buffer Preparation

+ Fermentation, Harvest & Separation

+ Ultrafiltration

+ Chromatography

Deactivation & Neutralization

Process Validation

Supports all aspects of filling & packaging.

a Blow/Fill/Seal systems

a Unscramblers

a Neck Banders

a Labelers

a Cottoners

a Cartoners

a Shrink Wrappers

a Blister Packers

a Over wrappers

a Accumulation Tables

a Case Sealers, Palletizers

a Batch/Date/Bar Coders

a Tamper Evident Features

a Fillers, Pluggers, Cappers

PRFC Inc, will help you to ask the right questions.

Computer hardware & software qualification

+ Automatic Inspection

+ Data Collection Systems

+ PC Based Systems

+ Distributed Control Systems

+ Programmable Logic Controllers

Laboratory equipment qualification

Autoclaves/ Incubators

Instrument Calibration

Method validation

Depyrogenation Ovens

Glassware Washers/Dryers

WE RENT KAYE EQUIPMENT TOO!!