DESIGN AND OPERATION OF STERILE COMPOUNDING PHARMACY CLEANROOMS Define the Contamination Control Requirements for Sterile Compounding Cleanrooms. Identify contaminant emissions from personnel and level of airborne contaminants. Specify the maximum size inert and biological particles allowed. Analyze existing compounding flow processes. Select appropriate surface contamination levels from ISO documents, FDA Standards and Specifications, Federal Standards and Pharmaceutical Standards and other appropriate standards and specifications. Apply defined values from the above standards and specifications to select controls for protecting the exposed processes. Recommend the Cleanliness Class of cleanroom and/or environmental control required. List the options of clean facilities suitable for compounding operations. Specify allowable contamination levels of compounding containers and glassware. Define protocols for cleanroom cleaning and maintenance. Provide proper cleanroom entry procedures, personnel clean-up, type of garments and garment cleaning per ASTM F51 Methods. Discuss training requirements. Establish procedures for certifying cleanliness to FDA Requirements. Identify similar existing cleanrooms and contamination control areas and their costs.
Cost for this consultation is $2,500 plus travel expenses.
LASER PRODUCTION CLEANROOMS AND AREAS Define the Contamination Control Requirements for Laser Production Cleanrooms and Areas. Identify contaminant emissions from personnel, processing machines, microscopes, gas handling equipment and ovens. Identify their contribution to room airborne contaminant levels. Specify the maximum size inert particles allowed. Prepare a company Contamination Index. Select appropriate product surface contamination levels from Mil. Stds., Fed. Stds., NASA Stds,. ISO Stds., Navy Stds., FDA Stds., Pharmaceutical Stds., Medical Device Stds., Laser Stds., and other appropriate standards and specifications. Apply defined values from the above standards and specifications to laser parts being manufactured. Recommend the Cleanliness Class required for the manufacturing operations. Explain the type of clean facilities required for clean laser parts production. Determine compatibility of materials of construction for the facility and product. Discuss proper personnel actions within the cleanroom. Identify the needs for cleanroom training. Define protocols for machine, conveyor and cleanroom cleaning and maintenance. Provide proper personnel entry procedures, personnel clean-up, type of garments and garment cleaning per ASTM F51 Methods. Establish procedures for certifying cleanliness to ISO Std. and Fed Std. Requirements. Identify similar existing areas and their costs.
Cost for this consultation is $2,600 plus travel expenses.
DESIGN AND OPERATION OF AUTOMOTIVE CLEAN PARTS FACILITIES AND CLEANROOMS Define the Contamination Control Requirements for Automotive Clean Parts Facilities and Cleanrooms.
Identify contaminant emissions from personnel, processing machines and conveyors. Identify their contribution to room airborne contaminant levels. Specify the maximum size inert particles allowed. Prepare a company Contamination Index. Select appropriate product surface contamination levels from
Mil. Stds., Fed. Stds., ISO Documents, Automotive Stds., Engine Mfg. Stds., German Stds., Foreign Stds., and other appropriate standards and specifications Apply defined values from the above standards and specifications to clean parts being manufactured. Recommend the Cleanliness Class required for manufacturing operations. Explain the type of clean facilities required for automotive clean parts production. Determine compatibility of materials of construction for the facility and product. Discuss proper personnel actions within the cleanroom. Identify the needs for cleanroom training. Define protocols for machine, conveyor and cleanroom cleaning and maintenance. Provide proper personnel entry procedures, personnel clean-up, type of garments and garment cleaning per ASTM F51 Methods. Establish procedures for certifying cleanliness to ISO Std. and Fed. Std. Requirements. Identify similar existing areas and their costs.
Cost for this consultation is $2,600 plus travel expenses.
PLANNING GENERAL INDUSTRY CLEANROOMS Define the Contamination Control Requirements for the product. Specify the maximum size inert and or biological particle allowable. Analyze existing production flow processes. Select appropriate surface contamination levels from Mil. Stds., Fed-Stds., NASA Stds., International Stds., from ISO documents, Army Stds., Air Force Stds., Navy Stds., Automotive Stds., Engine Stds., FDA Stds., Pharmaceutical Stds., Medical Device Stds. and other appropriate standards and specifications. Apply defined values from the above standards and specifications to select the appropriate cleanroom for protecting the manufacturing process. Recommend the Cleanliness Class of cleanroom or environmental control required. List options of cleanrooms and clean areas suitable for your product’s manufacture. Determine compatibility of materials for construction of the project and product. Specify allowable surface contamination levels of each product component. Suggest the best product flow for manufacturing and the contamination level at each work station. Identify a range of clean production solutions and the costs to implement these recommendations. Discuss the best materials of construction. Identify similar existing cleanrooms and contamination control areas.
Cost for this consultation is $2,500 plus travel expenses.
MEETING PHARMACEUTICAL CLEANROOM REQUIREMENTS Determine values for specific pharmaceutical product cleanliness. Analyze proposed or existing production flow processes. Discuss current cleanroom conditions and cleanroom construction. Specify allowable surface contamination levels for floors, walls, ceilings, workstations and equipment. Select appropriate surface contamination levels from International Standards, ISO documents, FDA Stds., Federal Stds., Private Pharmaceutical Company Stds., Medical Device Stds., and many other existing standards and specifications. Apply defined values from the above standards and specifications to select the appropriate cleanroom for protecting the Pharmaceutical Manufacturing Process. Suggest the best product flow for manufacturing and the contamination level at each work station. Identify a range of clean production solutions, cleanrooms and clean areas. Show how to meet FDA cleanroom certification. Discuss the roll personnel emission and actions affect operations. Establish your company Personnel Contamination Index. Mathematically compute expected cleanroom contamination levels prior to stating production operations. Discuss the instruments needed to monitor the cleanroom. Provide the costs to implement all of the above recommendations.
Cost for this consultation is $2,600 plus travel expenses.
DESIGN AND OPERATION OF MEDICAL DEVICE CLEANROOMS Define the Contamination Control Requirements for Medical Device Cleanrooms. Identify contaminant emissions from personnel and level of airborne contaminants. Specify the maximum size inert and biological particles allowed. Prepare company Contamination Index. Select appropriate surface contamination levels from ISO documents, FDA Standards and Specifications, Federal Standards and Medical Device Standards and other appropriate standards and specifications. Apply defined values from the above standards and specifications to select controls for protecting the exposed processes. Recommend the Cleanliness Class of cleanroom required. Explain the type of facilities suitable for Medical Device Production. Determine compatibility of materials of construction for the facility and product. Discuss proper personnel actions within the cleanroom. Identify the need for cleanroom training. Define protocols for cleanroom cleaning and maintenance. Provide proper cleanroom entry procedures, personnel clean-up, type of garments and garment cleaning per ASTM F51 Methods. Establish procedures for certifying cleanliness to FDA Requirements. Identify similar existing cleanrooms and their costs.
Cost for this consultation is $2,500 plus travel expenses.
DESIGN AND OPERATION OF PLASTIC EXTRUSION CLEANROOMS Define the Contamination Control Requirements for Plastic Extrusion Cleanrooms. Identify contaminant emissions from personnel, plastic extruders and processing machines and their contribution to room airborne contaminant levels. Specify the maximum size inert and biological particles allowed. Prepare company Contamination Index. Select appropriate surface contamination levels from ISO documents, FDA Standards and Specifications, Federal Standards, Pharmaceutical Standards, Medical Device Standards and other appropriate standards and specifications. Apply defined values from the above standards and specifications to select controls for protecting the exposed extrusion processes and plastic extrusions. Recommend the Cleanliness Class required over the extruders and in the cleanroom. Explain the type of clean facilities required for medical extrusion production. Determine compatibility of materials of construction for the facility and product. Discuss proper personnel actions near the extruders and within the cleanroom. Identify the needs for cleanroom training. Define protocols for machine and cleanroom cleaning and maintenance. Provide proper personnel entry procedures, personnel clean-up, type of garments and garment cleaning per ASTM F51 Methods. Establish procedures for certifying cleanliness to ISO Stds., Fed Stds. and FDA Requirements. Identify similar existing extruder clean areas and their costs.
Cost for this consultation is $2,600 plus travel expenses.
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