WATER Systems, Technology, Conservation...

CONTACT: Leonard B. Antosiak - Pharmaceutical Production TechSource® - P.O. Box 1145 -
Ann Arbor, MI 48106-1145 - (Telephone: 734.528.0444) - (eMail: ppt@2020comm.net) - (WEB PAGE: http://PharmaceuticalProductionTechSource.com)

WATER Systems, Technology, Conservation...

WATER Systems, Technology, Conservation and MUCH MORE...
(We specialize in engineered solutions for your sanitary liquid processing problems! Our experts service the pharmaceutical, beverage, food, chemical and industries that have water-related processing issues. We provide technology, products, and services from concept to design, to the installation and maintenance of your water system.)

The following topics are addressed on this page: - Water Systems Technology Conservation, Equipment, Products, Services... and "Sustainable Design of Critical Utilities Innovative Processes and Applications"

Our expertise is in sanitary liquid processing, equipment, and engineering! The technologies we represent have specific applications within industries that consume large volumes of water. We provide system designs to turn-key installations: complete skidded systems; modular skids for field and multiple applications; custom fabrications for packaged USP purified water, and water-for-injection (WFI) systems and tanks. Using the latest equipment and water science, we are helping companies better understand and improve their water useage practices. We help companies prepare for a sustainable future!

We provide installation and startup assistance, training, warranty repairs and service after warranty expiration. Maintenance, and annual maintenance contracts are available if desired. In addition, we can custom-build your equipment: liquid and dry totes, tanks and vessels, agitators, in-tank blending, platforms, etc. We'll also provide you with field service and maintenance contracts to help service your equipment.

Water Systems
Technology, Conservation, Equipment, Products, Services...

Water System's Design and Installation: our areas of expertise enable us to provide the pharmaceutical, food, and beverage industries turnkey installations ranging from suppository manufacturing to process water utilized in yogurt production. With extensive experience in the fields of ultrapure USP and WFI water as well as processing systems, we can provide the highest degree of quality available. This includes ozone sanitization and compliance with USP XXIII TOC and conductivity. We provide all the necessary validation and documentation to support installations and are in full compliance with all regulatory agencies, including OSHA.

Water Manufacturing: unique manufactured products have been developed in response to customer requests including special fittings and processing equipment. As well as our line of sanitary heat exchangers that can be used for cooling and heating applications. Most notabley for purified water, or, clean steam sample cooling or pump seal flush cooling. The sanitary heat exchanger was designed for pharmaceutical and biotech applications: WFI sampling, clean steam sampling, pump seal cooling, process heating and cooling, in-line sterilization and sanitization. Features include: all surfaces that contact pure water or steam are 25 RA or better at eliminating contamination from equipment; sanitary fittings allow the unit to be dismantled for cleaning to optimize operating conditions and heat exchange; the small inside diameter of the colling coil results in a high flow velocity; low volume of sample in the cooling coil assures quick sampling and fast response to changes in sample composition when used on continuous analyzers; the unit was designed to be self-draining, maximizing product recovery in process applications.

Skidded Versions: most of our systems can be skidded. These units can be fabricated for both potable or stationary applications, and are typically complete with instruments, controls, and are prewired for ease of installation. Skid systems may include pumps, tanks, mixing equipment, filters, expansion tanks, heat exchangers, interconnective valves and fittings as required by the application. Modular skids can be provided for assembly in the field or for multiple applications.

Custom Fabrication: our shop is at your disposal for virtually any size or shape fabricated from a stainless steel sheet, tube, pipe or plate. Our automatic welding equipment has a capability of 60" diameter with a 6" wall thickness. The following are some examples of our work: liquid and dry ingredients totes, portable and stationary hoppers, pump skids, completed processing skids, packaged USP purified water systems, prefabricated piping and ductwork, sinks and tables, surgical instruments, filter dollies, push carts and more!

Blending Technology: is a misunderstood and misapplied process for many companies. Dry-to-liquid blenders can provide rapid mixing with vast improvements in consistency and proudct quality. In-line blending can accurately mix varying rates of numerous ingredinets continuously, or, simply add one ingredient to a batch. This technology has increased in popularity because of continuous manufacturing techniques, and as an outgrowth of the beverage and food industries. High-shear blending can be used for difficult-to-mix solutions and suspensions, and is an economical method to achieve excellent results. Agitators conger up the image of a top mounted propeller type mixer, they're usually cost effective and suitable for a myriad of applications. In-tank blending can include basic agitation as well as high-shear mixing, and can be expanded to include surface scraping and counter rotation in vitually any combination.

Tanks and Vessels: properly designed and fabricated equipment can not only improve manufacturing quality and timeliness, but also improve profits through enhanced efficiencies. Processing tanks can be configured in a myriad of sizes and shapes with almost any feature. However, finishes should be an area of special concern when manufacturing your tank. Mixing vessels combine the quality and customization of pressure and/or process vessels with specialized in-tank or external mixing to achieve the highest quality and most consistent product mixing. Pressure vessel capability increases the versatility of other vessels by allowing process parameters within the designed pressure of the unit, and provides for a wider range of operational possibilities. Portable tanks can be made portable with addition of casters, lifting channels or sub-bases including weighing cells to fit the application. Many processes including food and "food like" products require kettles with a hemispherical bottom design. Inherently the cleaning, evacuation and mixing are eased by the design. Features like a tilting body, agitator lift/tilt units make this design versatile and functional. Ingredient tanks with multi-compartment design can be used to reduce initial expense as well as to minimize space requirements. Units can be constructed in single or double wall design for heating, cooling, or, tempering products. Silo tanks provide large bulk storage up to 50,000 gallons for applications within the facility or outside. Aseptic vessels are used where sterility and/or containment is critical. Steam seals, CIP capability, special venting and other critical design aspects must be properly integrated into the unit. USP purified and WFI tanks for the storage and distribution of USP water requires a vast working knowledge and understanding of technical issues from electropolishing to ozonation. This creates and large list of options and design constraints.

Sanitary Liquid Filters: available in both disposable and replacement cartridge configurations. They are available in sanitary designs for applications of coarse straining through submicron absolute filtration, in virtually limitless media materials, sizes, flow rate and process parameters. Finer filtration is also available through ultrafiltration and reverse osmosis. Sanitary gas filters, similar to those used for liquid applications are used in ultrapure and sterile environments includeing reactive and inert gases with a variety of styles, sizes, and materials. Sanitary vent filters are commonly used in purified and sterile applications where venting of containers, vessels, or piping is required and where invasive contamination must be avoided. Sintered metal filters provide optional strength,chemical and temperature resistance and other advantages for special applications. Sanitary screen filters are ideal where small volumes of particulate matter must be removed from process lines. They are inexpensive, easy to mount and can be used in lieu of a standard gasket. Sanitary basket filters provide an easy inexpensive method for removal of particulate in substantial volume using compact, often cleanable modular units. Pore sizes vary from 2 micron to 1/4 inch. Sanitary strainers are used for the removal of larger particulates and are often used for protection prior to mechanical equipment and instruments.

Metering, Instruments and Controls: metering can be found in units of all sizes, shapes, designs, and accuracies. They can be used for blending both batch and continuously with single or multiple ingredients. Meters are availble with all standard connections, finishes, and ranges in the following types: mass flow, turbine, magnetic, positive displacement, and ultrasonic. State-of-the art controls cannot be understated. PLC systems including data acquisition are critical to operations, maintenance and validation. We pride ourselves on control capabilities and friendly user design.

Precision Liquid Filling - ControlLogix PLC Strain Gage Weigh Module Technology: this application is a 2-channel module with 2 load cell inputs used in conjunction with a ControlLogix PLC controller, and individual fill station load cells for a multi-station rotary liquid filler. This technology precisely controls the flow and weight of the liquid. It provides the control output, and the process control is based on weight to within 1 gram of product. This application is for liquid filling where each filling station has its own load cell under the container platform. This particular filler has 2 fill valves per head (coarse fill and fine fill), comparing the target full weight to the actual measured product weight in the container. The strain gage weigh module controls the flow rate and flow duration for each valve at the different stages of the process. The coarse fill valve has a high flow rate with a rough control fill function. The fine valve has a low flow rate with a precise control fill function. For any given container, the fill process starts initially with fine fill, changes to fine and coarse fill, and changes back to fine fill only to fine-tune the finished weight. The cost savings is derived from a more accurate fill (within 1 gram), eliminating over-fills and under-fills. This application is ideal for higher-volume expensive products, i.e., pharmaceuticals, milk, spirits, beers, etc.

Full Field Service and Maintenance: provided on all of our systems and components. You are provided with installation, startup assistance, training, warranty respairs/service, and after-warranty maintenance. Annual maintenance contracts can be configured for single or multiple systems, as well as for any regimen required by the plant. Customized contract can include daily, weekly, monthly, quarterly, biannual, or, annual service on any and/or all of the components and can be provided based upon a labor only, or, for parts and labor.

Technical Consulting for Equipment and Processing: We've worked extensively in the following processing areas: antiseptics, batch weighing, CIP systems, hair care products, purified and clean steam, sterile/aseptic injectables, suppositories, syrups, coatings, topicals, transdermal preparations, USP purified water, USP water-for-injection, beverage, food, and other water related processes. Our primary business is equipment, however, we recognize our obligation to provide support for the application of products through to their installation and start-up.

Sustainable Design of Critical Utilities
Innovative Processes and Applications:

A part of sustainability is the conservation of your resources. You want to improve your effectiveness, efficiencies, reduce costs, improve competitiveness, and maximize your processes and applications.The following information will help you attain those goals:

Potential Sustainability Issues: Impact(s) on natural resources - Usage and consumption - Contamination - Affect on natural resources, i.e., clean water and clean air - Environmental Impacts: Ground pollutants: waste water, chemicals, heat; Air pollutants: particulates, chemicals, heat; Water pollutants: chemicals, waste water, heat - Energy Utilization: electricity, steam and/or hot water, cooling media - Social Impacts: quality-of-life, contributions to society, familial implications, healthcare costs - Productivity Impacts: supply vs. demand, stock market (ROI), emerging economies - Economic Impacts: cost of goods produced, price of goods sold, consumer access, cost of R&D, emerging markets, trade balance(s)

Water is the Single Most Addressed Topic in the United States Pharmacopeia: Water is the largest commodity used, and addressed in the USP Monographs - Test methods - Information sections - General notes - Section references impacting water: <11>, <71>, <85>, <643>, <645>, <788>, <791>, <1078>, <1211>, <1231>, <1241> - Water Monograph in NF - USP Monographs for each water category - General notices and general information sections

Attitudes About Water Today: Generics are very competitive - "Carbon Footprints" need to be reduced and we need to green our sites - Budgets are tight - Utility costs are high - We need to use a "Risk Based Approach and PAT" (you can't test quality into products)

Previous FDA Inspection Attitudes: Take no risks with water, use heat and keep it hot - Companies incurred large initial capital costs and operating expenses - Systems often heated and then cooled - There were large utility requirements with electricity, steam and cooling - Significant waste water - Chemical waste was common

Technology Applications: Reverse Osmosis - Distillation - Continuous Electro-Deionization - and limited Ultra-Filtration are desireable technical applications

Direct Water System Issues: Energy consumption and carbon footprints - Waste and pollutants - Cost of goods produced

Direct and Indirect Energy Usages: Production and equipment - Process cooling - Process heating - Space conditioning (HVAC)

Electricity Useage: Pumps, RO and distribution, support utilities - Electrodeionization - Direct heating and/or cooling

Process Heating and Cooling: Steam - Hot water - Cooling media: chilled water, glycol, city and potable water, DX refrigerant, absorption refrigeration

Space Conditioning: Equipment rooms may be suitable for ventilation only, or, may require heating and/or cooling to maintain acceptable conditions - Continuously heated systems may impart heating load to occupied spaces (labs, production, etc.) and unoccupied spaces (plenums) - Insulation may offset a portion of the heat gain

Waste and Pollutants: Backwash streams - RO reject streams - Heated discharge - Regenerant chemicals - Derouge and passivation waste - Gaseous discharges - Filter media disposal - Treatment media disposal - Potable and treated water

Cost Impact on Products: Cost of water as a raw ingredient - Cost of water for cleaning - Cost of water for sanitization - Amortization - Maintenance - Operations (from real estate to staff)

Water System Design: Treatment Process Design: chemical analysis, user requirements ( quality and total volume), technology selection utilizing a balanced approach, sanitization methods - Storage and Distribution Design: user requirement (delivery rate and pressure), sanitization methods

Potential Areas for Greening: Pretreatment - Primary method of treatment: Deionization, Reverse Osmosis, Distillation - Secondary treatment - Distribution - Sanitization

Low Hanging Fruit: Motor controls - Sanitization regimen - Treatment and reuse of RO reject - Filtration - Control schemes

Motors: VFD's can result in payback on average ranging from 1 to 4 years depending on local energy costs and equipment size - VFD's average per year savings is 30%+

Sanitization: Ozone: savings are derived because water heating and cooling is not required; energy reduction during sanitization unlike heat sanitization - Small increase in initial capital costs, system dependent - No significant change in maintenance - Often, low operating cost - No water is wasted vs. chemical sanitization - Increased equipment utilization

Ozone's Maintenance Impact: Service and/or Calibration of O3 equipment: ozone generator (possible O2 equipment); dissolved ozone monitors (typically 2-3); ambient ozone leak detector; vent decomposers or vent devices; ozone destruct utraviotlet light - Reduction in rouging and repassivation

Green Potential: VFD's motors must be compatible - Ozone sanitization: unless majority of water is required hot; ozone eliminates the need for heat sanitization in your boiler and chiller capacity; reduces frequency of derouging and repassivation; more environmentally "friendly"

VFD Example: USP Purified Water Quality - 200 gallons per minute (gpm) - 3 recirculated loops: Loop #1 delivery up to 425gpm (40hp); Loop #1 annual cost at full speed = $7,500.00, at 50% speed = $940.00, annual savings based on 50/50 = $3,280.00 - Loop #2 delivery up to 600gpm (60hp); Loop #2 annual cost at full speed = $11,250.00, at 50% speed = $1,410.00, annual savings based on 50/50 = $4,920.00 - Loop #3 polishing only (25hp) - 20,000 gallon storage - Ambient operations and ozone sanitization - Financial Analysis: savings based on the addition of 3 VFD's to an existing system calculated using the following client data; pumps run continuously at full maximum power; based on estimated useage, VFD installation will allow average operation at 50% (12.5bhp) output approximately 12 hours per day (estimate may be conservative); energy cost is $0.0287/kWh (summer/seasonal); Loop #3 annual cost at full speed = $3,700.00, annual cost at 50% speed = $463.00, savings based on 50/50 = $1,619.00 - Total Savings annual costs for all 3 Loops at full speed = $22,450.00, annual cost at 50% speed = $2,813.00, savings based on 50/50 = $9,819.00 - Summary: Estimated annual cost savings was $9,819.00 (approximately 55%, actual savings after 24 months was 63.7%); Estimated payback period was 4.2 years; Note: savings does not account for reduced equipment wear-and-tear and associated maintenance reduction; lowered coolant demand based on less heat input to water; reduced ozone comsumption and associated air, electrical and coolant - Payback would have been lower if energy cost wasn't already very low

Ozone Advantages: Increase asset utilization - Improved water quality reliability - Capital avoidance - More safety with no steam, hot equipment or chemicals - Lower operating costs - Reduced energy cost and reduced carbon foot print - Advantages over chemical sterilization: reduced water usage, reduced chemical disposal cost, reduced excursions and related cost avoidance

Ozone Disadvantages: Possible added cost(s) (offset against other equipment savings): ozone generation equipment and monitoring equipment, oxygen source if required, and ozone destruction equipment - Potential pH shift if the design isn't proper - Slower removal of established biofilm - Confirmation of material compatibility (are they the same) - Training is different - May be a concern with oxygen sensitive products - Safety issues must be understood - The significance of each advantage and disadvantage is dependent upon the spcific system operating conditions, and the alternative sanitization approach being compared to ozone.

Ozone Sanitization GPG: Chapter #9 is "Retrofitting Water Systems with Ozone Sanitization Capability - Chapter #12 is Ozone and Heat Comparison - Chapter #13 Ozone and Chemical Sanitzation Comparison

Conservation Philosophy for Water, Energy, and Cost Savings: Design Philsophies and System Planning: establishing appropriate quality attributes, operational ranges, and establishing life cycle costs - Pretreatment Options: alternative filtration options, a quality pretreatment will help assure a reliable final treatment, alternative materials of construction, and optimizing regeneration/backwash frequency - Final Treatment Options: reuse options for waste water, CEDI vs. regenerated resin (pros vs. cons), MEF vs. VC distillation comparison - Storage and Distribution: optimization of equipment sizing, alternative distribution examples (pros vs. cons), materials of construction, energy consumption (temperature and flow) - Instrumentation and Control: selecting a control strategy, added instruments can reduce operating costs, proper control saves energy - Microbiological Considerations: alternative sanitization methods, microbial enumeration, and frequency of sanitization

Process or Raw Material?: Fundamental inconsistencies regarding water systems: Is it the "Utility" that uses a complicated process to purify water? Does it make a critical pharmaceutical "raw material"? - Should you use sampling, testing, and triggers for: "Process control" using Alert and Action levels to assure maintenance of control like all other important processes? "Quality control" or, suitablility for use using Specifications and NOT Action Levels like all other raw materials? Or BOTH? - Does controlling the process eliminate the need to verify the FINAL quality of this unstable raw material?

Uses of Water Sampling Data: Used for "Process Control", follow data trends as indicators of control - Establish levels as triggers for remedial activity: Alert Level trigger when your at the outer edge of normal, no active response other than notification unless its frequent, and if its more frequent than normal, its an early sign of control slippage and action is needed - Action Level trigger when beyond the edge of normal, active remedial response plus notification to regain control before the water is unfit for use and fails Specification, should correct (C) root cause and prevent (P) recurrence (CAPA)

Impact on Real-Time Release (RTR): Tremendous cost incentive - Some road blocks to overcome: RTR is already possible with chemical testing, on-line testing in lieu of POU testing is possible, the actual practice is slowly being adopted, but is increasing - Is RTR possible with microbial testing: under certain circumstances, localized biofilms and speciation is a problem for on-line RMMs, speed advantages of POU RMM testing makes RTR possible, you'll need excellent system control and good POU history (all zeroes or very low levels so speciation is not an issue), "YES" it is possbile in certain circumstances

Credentials: we work with Mr. Joseph Manfredi on all of our sanitary liquid processing, equipment, and engineering projects. He has more than 33 years of experience in specializing in pharmaceutical liquid processing systems. In addition to working on projects with the beverage, food, and chemical industries addressing design, installation, fabrication, troubleshooting and training. Mr. Manfredi is experienced in USP water for injection, clean steam and purified water systems, liquids, ointments, creams, syrups, coatings. suppositories, solid dose manufacturing, pastes, gels, beverages, and food production. Mr. Manfredi was the driving force behind the establishment of a Pharmaceutical Engineering Program at the New Jersey Institute of Technology, and currently chairs its advisory committee. He also serves on the graduate faculty, teaching courses in the Engineering Masters Program. He teaches courses addressing: "principles of pharmaceutical engineering", "facility design", and the "design, operation and validation of water systems." Mr. Manfredi has extensively published on water-related subjects in both domestic and international journals. In addition, Mr. Manfredi teaches courses in affiliated topics lecturing for the PDA, ISPE, and the AWS. Mr. Manfredi's client list for consultation, design, and completed systems includes most major pharmaceutical manufacturers, as well as many Fortune 500 companies.

TechSource® is a full-service organization that will meet all of your water technological and service needs! Whether your needs call for componenets or packaged systems. We can provide design, individual components, and/or turn-key units. With extensive epertise is sanitary applications, we use only the highest grade components and competitive pricing. We can provide pharmaceutical, beverage and food companies with turnkey installations ranging from beverage processing to sterile WFI systems. We'll provide all of the necessary validation and documentation to support our installations and are in full compliance with regulatory agencies including OSHA.

Sanitary Stainless Filter Skid Built 2015:

Unit size: approximately 7' long x 4' wide x 7' tall

Tubing and Fittings: predominantly 1.5"

Material: 316LSS, 20 Ra ID finish

Filters: (3) Pall filters designed for 150psi designed pressure are piped in series

BS&B Rupture Discs: (2) - 2" are installed with 4 spares, all rated for 75psig at 250 degrees F

Ball Valves: (2) - 1.5" 316LSS ball valves and (2) 0.5" 316LSS ball valves

Valves: (3) - 1.5" 361LSS Gemu diaphragm valves with sanitary end connections, (1) - 0.5" and (1) - 2" x 0.75 special GMP valve

Pressure Gauge: (1) rated for full vacuum to 100psi

Documentation: full pharmaceutical documentation included

Condition: never installed or used, still in the crate

PLEASE NOTE: Pharmaceutical Production TechSource® makes every reasonable attempt to ensure the accuracy of the information we provide for each piece of equipment or part. The purchaser should verify any information or specifications with either their knowledge of the equipment, or, have the equipment inspected by a qualified person. Measurements and shipping weights are approximated or estimated. We are not responsible for any errors or omissions contained in any advertising materials, including this website, as well as any quotation or other documents which may contain a description of the equipment. All quotes are valid for 30 days, and all goods are subject to prior sale. Prices do not include creighting, freight, insurance, taxes, fees, etc.

PLEASE NOTE: Quotes for equipment DO NOT include crating, freight, or insurance costs (CFI), taxes, tariffs, etc. are additional.

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