/ By Panorama Consulting & Engineering Inc. / Pharmaceutical Industry/ 0 Comments

Periodic Assessment

In Pharmaceutical and Biopharmaceutical manufacturing industries, per ASTM E 2500, as a part of operations & continuous improvement, qualified systems must be periodically assessed until the systems are decommissioned. The purpose of periodic assessment is to ensure product quality and patient safety are not affected by any changes that may have occurred since the time of equipment release.

What is included in Assessment?

  • Change controls and Deviations
  • Original qualification documentation
  • SOP (Stand Operating Procedures)
  • P&ID’s Walk down 
  • Maintenance records in Computer Maintenance Management System (CMMS) software

Change Controls and Deviations Review: Keywords related to the system play a crucial role in searching the records in Quality Management Software for both Change Controls and Deviations. Records might be missed if proper search is not conducted.

Original qualification documentation: Initial qualification documentation should be reviewed for the required assessment duration to find the gaps and to reflect the company’s current policies and procedures.

SOP (Standard Operating Procedures): SOP’s related to the system operation and maintenance must be reviewed and confirmed with the System Owner to ensure that the procedures are current and whatever changes are made to SOP’s during the review period are done under appropriate change control procedures.

P&ID’s Walk down: Walking down the system P&ID’s are an important part of the periodic assessment as this confirms whether the P&ID is reflecting the current state of the system or not. 

Maintenance Records Review: Annual Workplans, Calibration records, Validation events, General Work Orders and Preventative Maintenance plans to be reviewed as a part of periodic assessments to ensure that the system is being calibrated, maintained and functioning properly.

 

 
Though the procedures are efficient in Pharmaceutical and Biopharmaceutical manufacturing industries, there are chances that some of the changes could be missed or not tracked in the Change Controls. Also, as the use of Single-Use technology is growing, chances of switching the equipment/instrumentation by the personnel without any proper change control is very likely since they are portable and doing so will save time. 

Performing all the activities listed above during the periodic assessment helps to identify the gaps and rectify the same which in turn ensures that the Product Quality and Patient Safety are consistent.

 

Design For Safety Equipment and design
/ By Panorama Consulting & Engineering Inc. / Project Management • Safety • System design/ 0 Comments

Design for safety

System safety

System Safety is the application of engineering and management principles, criteria, and techniques to optimize all aspects of safety within the constraints of operational effectiveness, time, and cost throughout all phases of the system life cycle. It is a planned, disciplined and systematic approach to preventing or reducing accidents throughout the lifecycle of a system

Primary concern is the management of risks through:

  • Risk identification, evaluation, elimination & control through analysis, design & management

History of system safety

Design Safety arose in the 1950s after dissatisfaction with the fly-fix-fly approach to safety. Design Safety was first adopted by the US Air Force. It led to the development of mil-std-882 Standard Practice for System Safety (v1 1960s). The basic concept of System was rather than assigning a safety engineer to demonstrate that a design is safe, safety considerations were to be integrated from the design phase of the project.

Founding principles

Safety should be designed in

  • Critical reviews of the system design identify hazards that can be controlled by modifying the design
  • Modifications are most readily accepted during the early stages of design, development, and test
  • Previous design deficiencies can be corrected to prevent their recurrence

Inherent safety requires both engineering and management techniques to control the hazards of a system

  • A safety program must be planned and implemented such that safety analyses are integrated with other factors that impact management decisions

Safety requirements must be consistent with other program or design requirements

  • The evolution of a system design is a series of tradeoffs among competing disciplines to optimize relative contributions
  • Safety competes with other disciplines; it does not override them

The main principles of Safe design are:

  • Inherent safety
  • Safety factors
  • Multiple independent safety barriers

Inherently safe design 

Inherent: belonging to the very nature of the person/thing (inseparable). It is recommended that Inherent safe design should be the first step in safety engineering. Change the process to eliminate hazards, rather than accepting the hazards and developing add-on features to control them, unlike engineered features, inherent safety cannot be compromised.

Minimize inherent dangers as far as possible by considering the following:

  • Potential hazards are excluded rather than just enclosed or managed
  • Replace dangerous substances or reactions by less dangerous ones (instead of encapsulating the process)
  • Use fireproof materials instead of flammable ones (better than using flammable materials but keeping temperatures low)
  • Perform reactions at low temperatures & pressures instead of building resistant vessels

Safety Factors

Factors of safety (FoS), also known as safety factor (SF), is a term describing the load carrying capacity of a system beyond the expected or actual loads. Essentially, the factor of safety is how much stronger the system is than it usually needs to be for an intended load. Safety factors are often calculated using detailed analysis because comprehensive testing is impractical on many projects, such as bridges and buildings, but the structure’s ability to carry load must be determined to a reasonable accuracy.

When the material used is under strength, factor of safety covers uncertainties in material strength. It covers poor workmanship. It also covers unexpected behavior of the structure and natural disasters. Stresses are produced which may be very high. Factor of safety may take care of these loads during construction. Presence of residual stresses and stress concentrations beyond the level theoretically expected.

Multiple Independent Safety Barriers

Safety barriers are arranged in chains. The aim is to make each barrier independent of its predecessors so that if the first fails, then the second is still intact, etc. Typically, the first barriers are measures to prevent an accident, after which follow barriers that limit the consequences of an accident, and, finally, rescue services as the last resort.

The basic idea behind multiple barriers is that even if the first barrier is well constructed, it may fail, due to unforeseen reason, and that the second barrier should then provide protection. The major problem in the construction of safety barriers is how to make them as independent of each other as possible. If two or more barriers are sensitive to the same type of impact, then one and the same destructive force can get rid of all of them in one swoop.

These three principles of engineering safety – inherent safety, safety factors, and multiple barriers are quite different in nature, but they have one important trait in common. They all aim at protecting us not only against risks that can be assigned meaningful probability estimates, but also against dangers that cannot be probabilized, such as the possibility that some unforeseen even triggers a hazard that is seemingly under control. It remains, however, to investigate more in detail the principles underlying safety engineering and, not least, to clarify how they relate to other principles of engineering design.

 

 

/ By Panorama Consulting & Engineering Inc. / MEP • System design/ 0 Comments

Ten reasons why your project requires an MEP Consulting Firm

Any project is successful when the right team works on it. For any construction or renovation project an MEP consulting firm is just as important as an architect or a builder. MEP stands for Mechanical, Electrical and Plumbing; a type of engineering that focuses on creating a safe environment for human use.
There are various reasons why MEP consultants are highly important for any building project.

We’ve listed down the top ten reasons.

  1. Mechanical – For any building project, residential or commercial, heating and ventilation services are essential. This is where the MEP engineers step in. They are responsible for the installation and maintenance of air conditioners, heaters, exhaust and smoke control. An MEP consultant will ensure their designs provide comfort and run efficiently.
  2. Electrical – Electrical services are indispensable. Your project will be incomplete without electricity and lighting. MEP consultants are responsible not just for lighting but also other electrical services such as fire alarms, security systems, smoke alarms etc. They provide solutions to the best services that are energy efficient and environment friendly.
  3. Plumbing–The plumbing aspect focuses on fire suppression systems as well as gas delivery systems in medical and laboratory settings. They are also responsible for water and waste management systems such as drinking water, irrigation water, sewers etc.
  4. Effective design – MEP consultants provide the best design solutions that are cost effective and worthwhile in the long run. These designs should not only employ the most recent and competent technologies but also provide foresight to ensure maximum lifecycle.
  5. Environment friendly – Whether it is energy conservation or water conservation, the experts certainly know the best. These consultants aim at providing services that utilize environment friendly products in order to reduce excessive consumption of resources.
  6. Cost Efficient – Every project that you take up has a stipulated budget that needs to be followed. With the help of MEP engineers not only do you manage to stay inside budget but also end up with systems that will be cost efficient in the long run.
  7. Optimum use–The expertise of MEP engineersensures that the products and systems required for your project provide maximum utilization. They ensure that maintenance of systems is limited and simple and workers are well trained to handle issues, if any.
  8. . Indoor environment –While focusing on creating an ecofriendly environment for the outdoors, it is also vital to build a safe and healthy environment indoors. Indoor environment quality refers to the use of natural daylight, moisture control, optimizing systems etc. A healthy indoor environment equates a safer environment for everyone.
  9. Building mechanism –Every system is connected to centralized hardware and software networks that control the indoor and outdoor features in a building. For example, your construction project requires HVAC commissioning; MEP consultants will cover the entire procedure for the project. Automation systems are required to build and maintain a building’s optimal operational performance and ensure safety and comfort the occupants.
  10. Expertise- It is always better to leave the job in the hands of the one that knows the best. MEP consultants are highly trained and experienced in their field. They work closely with architects and owners to provide successful coordination of building systems.

Panorama offers a variety of services in the mechanical, electrical and plumbing divisions for pharmaceutical and chemical sectors. Our specialized services will help your company with the sustenance it requires. We are a leading MEP Consulting Firm in Mumbai with numerous successful projects.

/ By Panorama Consulting & Engineering Inc. / Process Engineering • System design/ 0 Comments

FDA’s role in plant design

If you are involved in any type of manufacturing that is regulated by the FDA, FDA regulatory consulting firms can help you!

FDA consultants (who are all former employees of the FDA or have extensive industry experience) can assist with all phases of the manufacturing process, from single rooms to entire plants, computer systems to manufacturing and processing equipment, design to verifications and validations.

FDA consulting and FDA training services typically include:

  • master and batch record design and reviews
  • specification development (components, in-process, and finished product)
  • supplier audits
  • medical device design history file (21 CFR 820.30)
  • dietary supplements product design
  • equipment verification
  • process validation (prospective validation, retrospective validation, and revalidation)
    • DQ (Design Qualification)
    • IQ (Installation Qualification)
    • OQ (Operational Qualification)
    • PQ (Prospective Qualification)
  • cleaning validation (all industries)
  • GMP (Good Manufacturing Practices) and HACCP (Hazard Analysis and Critical Points)
  • stability studies
  • clean rooms
  • sterility
  • calibration
  • PM (Preventive Maintenance) and DM (Demand Maintenance)
  • plant design
  • computer system development and validation
    • ERP software (Enterprise Resource Planning)
    • data collection and storage systems
    • production equipment
    • system software for manufactured products


FDA’s role in plant design:

  1. cGMP requirements

    1. Design & Construction features
    2. Lighting
    3. Ventilation, air filtration, air heating and cooling
    4. Plumbing
    5. Sewage & refuse
    6. Washing & Toilet facilities
    7. Sanitation
    8. Maintenance

 

  1. cGMP Coverage of design
    FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. Compliance Programs are made available to the public under the Freedom of Information Act.
    Compliance Programs do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used as long as the approach satisfies the requirements of the applicable statutes and regulations. FDA’s Compliance Programs are organized by the following program areas:

    • Biologics (CBER)
    • Bioresearch Monitoring (BIMO)
    • Devices/Radiological Health (CDRH)
    • Drugs (CDER)
    • Food and Cosmetics (CFSAN)
    • Veterinary Medicine (CVM)

 

  1. Facilities & Equipment Systems
    • Cleaning & maintenance
    • Facility layout and air handling systems for prevention of cross-contamination (e.g. Penicillin, beta-lactams, steroids, hormones, cytotoxics, etc.)
    • Specifically designed areas for the manufacturing operations performed by the firm to prevent contamination or mix-ups
    • General air handling systems
    • Control system for implementing changes in the building
    • Lighting, potable water, washing and toilet facilities, sewage and refuse disposal
    • Sanitation of the building, use of rodenticides, fungicides, insecticides, cleaning and
    • Sanitizing agents

 

  1. Preapproval Coverage of Design/Preapproval Inspections/Investigations
    The addition of any new drug to a production environment must be carefully evaluated as to its impact on other products already under production and changes that will be necessary to the building and facility. Construction of new walls, installation of new equipment, and other significant changes must be evaluated for their impact on the overall compliance with GMP requirements.
    For example, new products, such as cephalosporins, would require that the firm demonstrate through appropriate separation and controls that cross-contamination cannot occur with regard to other products being made in the same facility. Also, facilities that may already be operating at full capacity may not have adequate space for additional products


Quality Systems Approach to Pharmaceutical cGMP Regulations
Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.

Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understanding from drug development to the commercial manufacturing processes and for post-development changes and optimization.

The CGMP regulations, when viewed in their entirety, incorporate the concept of quality by design. This guidance describes how these elements fit together.

For more information on FDA consulting services for plant design or to schedule a consultation, please contact us.

Continuous Distillation Column Design
/ By Panorama Consulting & Engineering Inc. / Process Engineering • Project Management • System design • Utility Optimization/ 0 Comments

Procedure for Continuous Distillation Column Design

Distillation is used to separate components in a feed mixture based upon their relative boiling points. A simple, continuous distillation column can make the separation between two components into two product streams. In multi-component systems, the two main components to be separated are designated as the light and heavy keys. The light key is the more volatile component in greater purity in the top product stream, and the heavy key is the less volatile component in greater purity in the bottom product stream.

Vapor-Liquid Equilibrium

The starting point upon which all column design is based is to accurately determine the relative volatility of the key components to be separated. Using a mass and energy balance simulation program. The user must set up the basis of the simulation by selecting an appropriate fluid package and the components present in the feed. Activity coefficients, estimated by the program or provided by the user, are used to relate non-ideal component interactions.

Column Operating Objectives

The first step in column design is specifying the column operating objectives. These are defined by a primary product composition and an optimal recovery of the product from the waste, recycle or less important by-product stream. These specifications should be in terms of the heavy key impurity in the top stream and the light key impurity in the bottom stream.

Operating Pressure

Once the top and bottom stream compositions are specified, the dew point of the top stream and the boiling point of the bottom stream may be determined at various pressures. An operating pressure should be selected that allows acceptable temperature differences between available utilities because the overhead vapor must be condensed and the bottom liquid reboiled.

When possible, atmospheric or pressure operation of the column is preferred in order to avoid requiring a vacuum system. However, another consideration is component heat sensitivity, which may require lower pressure operation to avoid fouling, product discoloration or decomposition. Often the relative volatility is also improved at lower pressures.

R/Dmin & Nmin and Feed Stage Estimation

Using the simulation program, shortcut procedures based upon total reflux operation allow the minimum reflux ratio (R/Dmin) and minimum number of ideal separation stages (Nmin) to be determined. Using an actual reflux ratio of 1.2 times the minimum reflux ratio will allow an optimal number of stages to be estimated as well as an appropriate feed stage.

Rigorous simulation of the distillation at a given feed rate and composition may now be accomplished by specifying the following: top and bottom product compositions, number of stages, feed stage, and top and bottom pressure.

Parametric cases of this simulation should be used to verify the estimated number of stages and feed location. Add and subtract stages from both the stripping and rectifying section of the column. Do this until the required reflux ratio becomes approximately 1.2 times the minimum reflux ratio, or the trade off between utility usage and the number of stages appears optimal for the specific column. As more total stages are used, the required reboiler duty will decrease until there are diminishing returns.

Diameter and Height of the Column

At this point, the distillation process is well defined, leaving the column diameter and height to be determined. The chosen design case from the simulation program provides the internal liquid and vapor flows and their physical properties for every stage of the column. The column diameter is chosen to provide an acceptable superficial vapor velocity, or “Fs factor”. This is defined as vapor velocity (ft/sec) times square root of vapor density (lb/ft3), and liquid loading defined as volumetric flow rate (gal/min), divided by the cross sectional area of the column (ft2). The column internals can be chosen as either trays or packing. Trayed columns must avoid flooding, weeping and downcomer backup. Packed columns must avoid flooding, minimum surface wetting and mal-distribution.

Project managers should understand and determine these five key design elements for the projects success. Cost, chemical interactions and equipment needs change in a non-linear fashion, as increased output is required. Qualified engineers should consider these critical steps for distillation column design.

RO/DI Water Systems
/ By Panorama Consulting & Engineering Inc. / System design • Utility Optimization • Waste Reduction/ 0 Comments

RO/DI Water Systems

RO/DI stands for Reverse Osmosis and Deionization. The product is a multi-stage water filter, which takes in ordinary tap water and produces highly purified water.

Tap water often contains impurities that can cause problems. These may include phosphates, nitrates, chlorine, and various heavy metals. Excessive phosphate and nitrate levels can cause an algae bloom. Copper is often present in tap water due to leaching from pipes and is highly toxic to invertebrates. An RO/DI filter removes practically all of these impurities.

There are typically four stages in a RO/DI filter:

  • Sediment filter
  • Carbon block
  • Reverse osmosis membrane
  • Deionization resin

If there are less than four stages, something was left out. If there are more, something was duplicated.

The sediment filter, typically a foam block, removes particles from the water. Its purpose is to prevent clogging of the carbon block and RO membrane. Good sediment filters will remove particles down to one micron or smaller.

The carbon, typically a block of powdered activated carbon, filters out smaller particles, adsorbs some dissolved compounds, and deactivates chlorine. The latter is the most important part: free chlorine in the water will destroy the RO membrane.

The RO membrane is a semi-permeable thin film. Water under pressure is forced through it. Molecules larger/heavier than water (which is very small/light) penetrate the membrane less easily and tend to be left behind.

The DI resin exchanges the remaining ions, removing them from the solution.

There are three types of RO membrane on the market:

  • Cellulose Triacetate (CTA)
  • Thin Film Composite (TFC)
  • Poly-Vinyl Chloride (PVC)

The difference between the three concerns how they are affected by chlorine: CTA membranes require chlorine in the water to prevent them from rotting. TFC membranes are damaged by chlorine and must be protected from it. PVC membranes are impervious to both chlorine and bacteria.

Reverse osmosis typically removes 90-98% of all the impurities of significance to the aquarist. If that is good enough for your needs, then you don’t need the DI stage. The use of RO by itself is certainly better than plain tap water and, in many cases, is perfectly adequate.

RO by itself might not be adequate if your tap water contains something that you want to reduce by more than 90-98%.

A DI stage by itself, without the other filter stages, will produce water that is pretty much free of dissolved solids. However, DI resin is fairly expensive and will last only about 1/20th as long when used without additional filtration. If you’re only going to buy either a RO or a DI, it would be best to choose the RO, unless you only need small amounts of purified water.

Duplicating stages can extend their life and improve their efficiency. For example, if you have two DI stages in series, one can be replaced when it’s exhausted without producing any impure water. If you have both a 5-micron sediment filter and a 1-micron filter, they will take longer to clog up. If there are two carbon stages, there will be less chlorine attacking the TFC membrane. Whether the extra stages are worth the extra money is largely a matter of circumstance and opinion.

RO/DI capacities are measured in gallons per day (GPD), and typically fall within the 25-100 GPD range. The main difference between these units is the size of the RO membrane. Other differences are (a) the flow restrictor that determines how much waste water is produced, (b) the water gets less contact time in the carbon and DI stages in high-GPD units than low-GPD units, and (c) units larger than 35 GPD typically have welded-together membranes.

As a result of the membrane welding and the reduced carbon contact time, RO membranes larger than 35 GPD produce water that is slightly less pure. This primarily affects the life of the DI resin.

Most aquarists won’t use more than 25 GPD averaged over time. If you have a decent size storage container, that size should be adequate. A higher GPD rating comes in handy, however, when filling a large tank for the first time or in emergencies when you need a lot of water in a hurry.

The advertised GPD values assume ideal conditions, notably optimum water pressure and temperature. The purity of your tap water also affects it. In other words, your mileage will vary.

An RO filter has two outputs: purified water and wastewater. A well-designed unit will have about 4X as much wastewater as purified water. The idea is that the impurities that don’t go through the membrane get flushed out with the wastewater.

There is nothing particularly wrong with the wastewater except for a slightly elevated dissolved solid content. It may actually be cleaner than your tap water because of the sediment and carbon filters. Feel free to water your plants with it.

/ By Panorama Consulting & Engineering Inc. / Pharmaceutical Industry • Process Engineering • Safety • Storage • Utility Optimization • Warehouse/ 0 Comments

Cleanroom

Typically used in manufacturing or scientific research, a cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To be exact, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical city environment contains 35,000,000 particles per cubic meter, 0.5 mm and larger in diameter, corresponding to an ISO 9 cleanroom which is at the lowest level of cleanroom standards.

Cleanroom Overview

Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, and are used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and Department of Energy.

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary; Ultra Low Particulate Air (ULPA) filters are used.

Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with self-contained breathing apparatus.
Cleanroom clothing is used to prevent substances from being released off the wearer’s body and contaminating the environment. The cleanroom clothing itself must not release particles or fibers to prevent contamination of the environment by personnel. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries and it can cause cross-infection between medical staff and patients in the healthcare industry for example.

Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls, face masks, frocks/lab coats, gowns, glove and finger cots, hairnets, hoods, sleeves and shoe covers. The type of cleanroom garments used should reflect the cleanroom and product specifications. Low-level cleanrooms may only require special shoes having completely smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping hazards since safety always takes precedence. A cleanroom suit is usually required for entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required.

Cleanroom Air Flow Principles

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall air returns around the perimeter of the zone. In horizontal flow applications, it requires the use of air returns at the downstream boundary of the process. The use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Graph for Pinch Point Analysis
/ By Panorama Consulting & Engineering Inc. / Process Engineering • System design/ 0 Comments

Pinch Point Analysis

Pinch Point Analysis is a systematic process design methodology consisting of a number of concepts and techniques that ensure an optimal use of energy. The Pinch is characterized by a minimum temperature difference between hot and cold streams and designates the location where the heat recovery is the most constraint.

The fundamental computational tool is the Problem Table algorithm. This tool allows the identifications of the Pinch, as well as of targets for hot and cold utilities.

The net heat flow across Pinch is zero. Consequently, the system can be split into two stand-alone subsystems, above and below the Pinch. Above the Pinch there is need only for hot utility, while below the Pinch only cold utility is necessary. For given ΔTmin the hot and cold utility consumption identified so far becomes Minimum Energy Requirements (MER). No design can achieve MER if there is a cross-pinch heat transfer.

The partition of the original problem in subsystems may introduce redundancy in the number of heat exchangers. When the capital cost is high, it might be necessary to remove the Pinch constraint in order to reduce the number of units. The operation will be paid by supplementary energetic consumption, which has to be optimized against the reduction in capital costs.

The result is that heat recovery problem becomes an optimization of both energy and capital costs, constraint by a minimum temperature approach in designing the heat exchangers. Stream selection and data extraction are essential in Pinch Analysis for effective heat integration.

The key computational assumption in Pinch Point Analysis is constant CP on the interval where the streams are matched. If not, stream segmentation is necessary

The counter-current heat flow of the streams selected for integration may be represented by means of Composite Curves (CC). Another diagram, Grand Composite Curve (GCC) allows the visualization of the excess heat between hot and cold streams against temperature intervals. This feature helps the selection and placement of utilities, as well as the identification of the potential process/process matches.

The synthesis of a Heat Exchanger Network consists of three main activities:

  • Set a reference basis for energy integration, namely:

-Minimum Energy Requirements (MER)

-Utility selection and their placement

-Number of units and heat exchange area

-Cost of energy and hardware at MER

  • Synthesis of heat exchanger network (HEN) for minimum energy requirements and maximum heat recovery. Determine matches in subsystems and generate alternatives.
  • Network optimization. Reduce redundant elements, as small heat exchangers, or small split streams. Find the trade-off between utility consumption, heat exchange area and number of units. Consider constraints

The improvement of design can be realized by Appropriate Placement and Plus/Minus principle. Appropriate Placement defines the optimal location of individual units against the Pinch. It applies to heat engines, heat pumps, distillation columns, evaporators, furnaces, and to any other unit operation that can be represented in terms of heat sources and sinks.

The Plus/Minus principle helps to detect major flow sheet modifications that can improve significantly the energy recovery. Navigating between Appropriate Placement, Plus/Minus Principle and Targeting allows the designer to formulate near-optimum targets for the heat exchanger network, without ever sizing heat exchangers.

Pinch Point principle has been extended to operations involving mass exchange. Saving water can be treated systematically by Water Pinch methodology. Similarly, Hydrogen Pinch can efficiently handle the inventory of hydrogen in refineries. Other applications of industrial interest have been developed in the field of waste and emissions minimization. The systematic methods in handling the integration of mass-exchange operations are still in development. In this area the methods based on optimization techniques are very promising.

/ By Panorama Consulting & Engineering Inc. / CIP/SIP/ • • • / 0 Comments

Maximize your CIP/SIP results

Tips and tricks for getting the most out of Clean in Place/Sterilization in Place results

Regardless of whether or not you are runninga manufacturing facility, a laboratory, or any other kind of operation that takes advantage of closed systems, you’re going to want to be certain that your operation is perfectly clean and completely sterilized on a regular basis.

This is especially true of those in the beverage, food, or pharmaceutical industry, where taking advantage of the best Clean in Place/Sterilization in Place services are absolutely mission critical to providing consistent and reliable results that pass industry specifications and requirements.

In an effort to help you better choose the right CIP/SIP professionals to deliver you the kind of results you’re counting on, here are just a handful of things you’ll want to think about before you contract any services at all.

Make certain that you’re always working with qualified professionals

The very first thing that you need to make sure you are doing when you are working with these kinds of professionals is that they are exactly that – professionals.

There are quite a few generalized cleaning operations out there that possess some of the tools and technology necessary to provide CIP/SIP results but not the experience, the specialized knowledge, or the wisdom to deploy these solutions appropriately in all circumstances.

No, instead, you’re only going to want to work with those that have the necessary qualifications, the necessary certifications, and the kind of experience – usually years of experience – that give you the confidence to know that the jobs going to get done the right way the first time around.

This is especially important when you are in an industry where contamination in a closed system can have dramatic and drastic consequences.

Only take advantage of services designed for your setup and your technology

Secondly, you’re going to want to be 100% certain that the CIP /SIP you have decided to work with are experienced in delivering the kind of clean in place and sterilization in place results you’re looking for with your particular technology setup.

Though almost every industrial setup is going to be unique in itself, the truth is most solutions have some kind of aseptic production technology, technology that needs to be cleaned without any exposure to outside contaminants whatsoever.

If you’re producing sterile products that must be packaged in sterile containers, CIP/SIP services are an absolute must!

The best CIP /SIP professionals are going to use isolators that make sure no air or oxygen makes it into a closed system, removing all potential for contamination almost entirely. Steam, hydrogen peroxide, and a handful of other specialized solutions may be deployed depending upon the kind of cleaning that you’re looking for and the manufacturing technology you’re using in your closed system.

Review the CIP/SIP experts you’ve worked with

Lastly, you’ll want to make sure that you can find at least a handful of appropriate outlets that give you the chance to review the CIP /SIP that you have chosen to work with.

This “inside information” straight from the mouths of people that have actually worked with CIP /SIP contractors and services will help business owners, management, and leadership choose the right experts going forward, and you’ll be contributing immensely to your industry and every other that needs to leverage these services later down the line.

Be honest and straightforward in your reviews so that people know exactly who to choose to work with moving forward.

 

/ By Panorama Consulting & Engineering Inc. / Safety/ • • / 1 Comment

Creating a Project Safety Plan

Any project that is within the fields of engineering or construction will come a high level of risk. It is possible to keep this risk low and prevent any serious accident occurring, however in order to do this you need to ensure that the safety plan you put in place is up to scratch. You need to tailor everything to your specific project and have a constant line of communication with team members regarding safety.

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