OUR CLEANROOM TRAINING CLASS CURRICULUM

STERILE COMPOUNDING CLEANROOMS AND FACILITIES

Contaminant Levels of Compounding Pharmacies; Personnel emission index; Equipment emissions; Dramatic visual contaminant demonstrations with a Contam-A-Light ---etc.

Pharmacy Filtration per FDA: Filter efficiencies required; filter materials, seals, gaskets and integrity; Rating methods; Filter life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of Compounding Pharmacies per FDA expectations; New, low cost, turbulent and laminar flow facilities; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000: HVAC; pressure, temperature, humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs etc. Operation and Maintenance of Compounding Pharmacies; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures, Training programs; Janitorial procedures for floor, walls, equipment;---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Aseptic air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Layout; Where To Apply Clean Pharmacy Benches.

Cleanliness Certification to meet FDA expectations; Automatic equipment to test facilities; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO and Fed Std.---etc.

Clean Garments for Compounding Pharmacies: Selection Process, Laundering and cleanliness evaluation per ASTM F51 method for garments. How to select garments, head covering, masks, gloves;--- etc.

MEDICAL DEVICE CLEAN PRODUCTION AREAS

Contaminant Levels of Medical Device Facilities; Personnel emission index; Inert and biological emissions; Equipment emissions; Particle identification; Visual contaminant demonstrations with Contam-A-Light; --etc.

Filtration per FDA for facilities: HEPA and ULPA filter efficiencies required; filter materials, seals, gaskets; Rating methods; Filter life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of Medical Device cleanrooms per FDA desires; New, low cost, turbulent and laminar flow facilities; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000: HVAC; pressure, temperature, humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs; Floor plans Construction specifications; Coving; Change rooms; Shoe cleaners; Air locks; Pass boxes; Shoe cleaners; Central vacuum systems; Utility distribution; Computers and phones; Cost of Construction ---etc.

Operation and Maintenance of Cleanrooms; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Change room layouts; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures: Air showers; Wash stands; Cleanroom wall penetrations/modifications; Contamination mapping; Training programs; Janitorial procedures for floor, walls, equipment;---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Aseptic air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Layout; Where To Apply Clean Benches.

Cleanliness Certification to meet FDA expectations; Automatic and manual equipment; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO, Fed Std., ASTM and Mil Std.---etc.

Clean Garments for Medical Device Cleanrooms: Selection Process, Laundering and cleanliness evaluation per ASTM F51 method. Garment emissions; How to select garments, head covering, masks, gloves;--- etc.

PLASTIC EXTRUSION CLEANROOMS

Contaminant Levels of Plastic Extrusion Facilities; Personnel emission index; Inert and biological emissions; Equipment emissions; Particle identification; Visual contaminant demonstrations with Contam-A-Light; --etc.

Filtration per FDA for facilities: HEPA and ULPA filter efficiencies required; filter materials, seals, gaskets; Rating methods; Filter Installation; Life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of Plastic Extrusion cleanrooms; How does FDA fit into the selection cleanrooms; New, low cost, turbulent and laminar flow facilities; HVAC considerations; Ducts and exhausts; Monitoring Instrumentation; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000; Pressure, temperature, light level; humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs; Floor plans; Construction specifications; Coving; Change rooms; Shoe cleaners; Air locks; Pass boxes; Shoe cleaners; Central vacuum systems; Utility distribution; Computers and phones; Cost of Construction --- etc.

Operation and Maintenance of Cleanrooms; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Change room layouts; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures: Air showers; Wash stands; Cleanroom wall penetrations/modifications; Contamination mapping; Training programs; Janitorial procedures for floor, walls and general equipment; Extruder locations; Extruder Maintenance and servicing; Extruder cleaning; Air flow over extruder---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Aseptic air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Layout; Where To Apply Clean Benches.

Cleanliness Certification to meet FDA expectations; Automatic and manual equipment; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO, Fed Std., ASTM and Mil Std.---etc.

Clean Garments for extruder operation areas: Selection Process, Laundering and cleanliness evaluation per ASTM F51 method. Garment emissions; How to select garments, head covering, masks, gloves;--- etc.

AUTOMOTIVE CLEAN PARTS FACILITIES

Contaminant Levels of Automotive clean parts Facilities; Personnel emission index; Inert emissions; Equipment emissions; Particle identification; Visual contaminant demonstrations with Contam-A-Light; --etc.

Filtration per ISO for clean parts facilities: HEPA filter efficiencies required; filter materials, seals, gaskets; Rating methods; Filter Installation; Life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of Automotive cleanrooms; How does ISO fit into the selection of cleanrooms; New, low cost, turbulent and laminar flow facilities; HVAC considerations; Ducts and exhausts; Monitoring Instrumentation; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000; Pressure, temperature, light level; humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs; Floor plans; Construction specifications; Coving; Change rooms; Shoe cleaners; Air locks; Pass boxes; Shoe cleaners; Central vacuum systems; Utility distribution; Computers and phones; Layout; Cost of Construction --etc.

Operation and Maintenance of Cleanrooms; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Change room layouts; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures: Air showers; Wash stands; Cleanroom wall penetrations/modifications; Contamination mapping; Training programs; Janitorial procedures for floor, walls and general equipment; Conveyor locations; Maintenance and servicing; Conveyor cleaning; Air flow conveyors---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Efficient layouts; Where To Apply Clean Benches.

Cleanliness Certification to meet ISO expectations; Automatic/manual test equipment; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO, Fed Std., ASTM and Mil Std.---etc.

Clean Garments for automotive clean areas: Selection Process, laundering and cleanliness evaluation per ASTM F51 method; Garment emissions; How to select garments, head covering, visors, gloves;---etc.

LASER PRODUCTION CLEANROOMS AND AREAS

Contaminant Levels of Laser cleanrooms; Personnel emission index; Inert equipment emissions; Particle identification; Contaminant demonstrations with a Contam-A-Light and a Mini laser light--etc.

Cleanroom Filtration per ISO for laser parts: HEPA and ULPA filter efficiencies; filter materials, seals, gaskets; Rating methods; Filter Installation; Life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of Laser cleanrooms; How does ISO and FDA fit into the selection of cleanrooms; New, low cost, turbulent and laminar flow facilities; HVAC considerations; Ducts and exhausts; Monitoring Instrumentation; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000; Pressure, temperature, light level; humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs; Floor plans; Construction specifications; Coving; Change rooms; Shoe cleaners; Air locks; Pass boxes; Shoe cleaners; Central vacuum systems; Utility distribution; Computers and phones; Layout; Cost of Construction --etc.

Operation and Maintenance of Cleanrooms; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Change room layouts; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures: Air showers; Wash stands; Cleanroom wall penetrations/modifications; Contamination mapping; Training programs; Janitorial procedures for floor, walls and general equipment; Conveyor locations; Maintenance and servicing; Conveyor cleaning; Air flow conveyors---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Efficient layouts; Where To Apply Clean Benches.

Cleanliness Certification to meet ISO expectations; Automatic/manual test equipment; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO, Fed Std., ASTM and Mil Std.---etc.

Clean Garments for automotive clean areas: Selection Process, laundering and cleanliness evaluation per ASTM F51 method; Garment emissions; How to select garments, head covering, hoods, gloves;--- etc.

SMALL PARTS PRODUCTION CLEANROOMS

Contaminant Levels of small parts Cleanrooms; Personnel emission index; Inert emissions; Equipment emissions; Particle identification; Visual contaminant demonstrations with Contam-A-Light; --etc.

Cleanroom Filtration per ISO for clean parts facilities: HEPA filter efficiencies; filter materials, seals, gaskets; Rating methods; Filter Installation; Life, testing, replacement; Filter banks; Ducting; Pre-filter selection ---etc.

Design and Construction of small parts cleanrooms; How does ISO fit into the selection of cleanrooms; New, low cost, turbulent and laminar flow facilities; HVAC considerations; Ducts and exhausts; Monitoring Instrumentation; ISO 14664-1 Class 1-9 and Fed Std. 209 Class 1-100,000; Pressure, temperature, light level; humidity, etc.; Material selection for floors, walls, ceilings, lights and appointments; Costs; Floor plans; Construction specifications; Coving; Change rooms; Shoe cleaners; Air locks; Pass boxes; Shoe cleaners; Central vacuum systems; Utility distribution; Computers and phones; Layout; Cost of Construction --etc.

Operation and Maintenance of Cleanrooms; ISO and Fed Std. concerns; Hand, arm and body movements to avoid; Change room layouts; Protocols for garmenting; Wash stand, hand driers, shoe cleaners, dressing procedures: Air showers; Wash stands; Cleanroom wall penetrations/modifications; Contamination mapping; Training programs; Janitorial procedures for floor, walls and general equipment; Conveyor locations; Maintenance and servicing; Conveyor cleaning; Air flow conveyors---etc., Check Lists Do's/Don't's.

Work Station Design, construction, operation and maintenance; Air flow; Start-up, checkout, test and certification; clean-up; Personnel disciplines; Efficient layouts; Where To Apply Clean Benches.

Cleanliness Certification to meet ISO expectations; Automatic/manual test equipment; Sampling plans; Certification steps, monitoring and conformance; Implementation of ISO, Fed Std., ASTM and Mil Std.---etc.

Clean Garments for small parts cleanrooms: Selection Process, laundering and cleanliness evaluation per ASTM F51 method; Garment emissions; How to select garments, head covering, hoods, gloves;--- etc.