Utility System Qualification for the Pharmaceutical Industry

Pharmaceutical equipment manufacturing is a highly regulated industry. Given the stress on product quality and the widespread impact of substandard production on public health and safety, utility system qualification is a critical step that companies must take towards ensuring that all their products comply with federal laws and regulations.

In pharmaceuticals, critical utilities like water and HVAC (Heating, Ventilation and Air Conditioning) systems form the backbone of the manufacturing process. As a result, these are treated, as products that need to satisfy FDA regulatory requirements and pharmaceutical manufacturing standards, just like raw materials and other equipment used in the industry.

The primary use of a utility system is to help pharmaceutical companies check the quality and safety of their products and to ensure they comply with the laws and statutes in the FDA dossier. Without meeting these requirements, a product may fail to be cleared for marketing.

To pass inspection, utilities must pass a string of qualitative and quantitative specifications. Different utility systems have different quality and standard criteria, designed on the basis of inputs from relevant departments and organizations as well as manufacturing and engineering provisions.

When a validation program is set in place for utility systems used in pharmaceutical, critical utilities should be first on the list. It’s important to focus on the design, qualification and monitoring of each utility system used in pharmaceutical or biotech companies, so their end product fulfills all pharmaceutical quality standards.

Utility system qualification is designed to ensure that utilities in use conform to health and safety regulations, as well as pharmaceutical manufacturing standards and cGMP guidelines.

Current good manufacturing practices (cGMPs) are FDA guidelines that check the design, control and monitoring of manufacturing facilities and processes. To comply with cGMP regulations, drugs and medicinal products need to be of the right quality, strength and purity, by way of adequately controlled and monitored manufacturing operations.

Steps in utility system qualification include implementing strong operating procedures, establishing extensive quality control systems, procuring a consistent quality of raw material supplies and maintaining dependable testing labs.

If such a broad control system is implemented in a pharmaceutical facility, it can help to control instances of mix-ups, contamination, errors, defects and deviations during the manufacturing process. Such pharmaceutical products are better able to meet public health and safety laws established by the FDA.

Pharmaceutical cGMP guidelines are flexible enough that all manufacturers are free to decide how to apply FDA controls in ways that fits their unique requirements. They can make use of a variety of processing methods, testing procedures and scientific designs to adapt their manufacturing processes to meet the laws.

Because of the flexibility of these laws, companies can use innovative approaches and sophisticated technology to implement a system of continual improvement in order to achievement a consistent quality of pharmaceutical supplies.

All pharmaceutical manufacturing facilities need to adhere strictly to FDA-approved regulations. There is a lot of stress on the compliance of facility design with cGMP regulations as well as the various procedures associated with pharmaceutical production, so drugs are manufactured under conditions that meet FDA approval.

Failure to meet FDA regulations can result in responsive action by the authorities against the product or the responsible facility, depending upon the seriousness of non-compliance. The company may have to recall the product under orders of the FDA, to ensure it does not cause additional harm or risk to the public.

cGMP requirements can be useful in ensuring the efficacy, quality and safety of pharmaceutical products by making sure facilities are in good operating condition, with sufficiently calibrated and well-maintained equipment, trained and experienced staff and reliable and efficient processes.

While a utility system cannot affect product quality on its own, it forms an integral part of the manufacturing process. Panorama helps you set up validation processes as per your needs.

Wastewater Treatment Process

Wastewater treatment is the process of converting wastewater – water that is no longer suitable for use – into water that can be discharged back into the environment. Its treatment aims at reducing the contaminants to acceptable levels to make the water safe for discharge back into the environment.

There are two wastewater treatment plants namely chemical or physical treatment plant, and biological wastewater treatment plant. Biological waste treatment plants use biological matter and bacteria to break down waste matter. Physical waste treatment plants use chemical reactions as well as physical processes to treat wastewater. Biological treatment systems are ideal for treating wastewater from households and business premises. Physical wastewater treatment plants are mostly used to treat wastewater from industries, factories and manufacturing firms. This is because most of the wastewater from these industries contains chemicals and other toxins that can largely harm the environment.

The wastewater treatment is as follows:

  1. Wastewater Collection

This is the first step in wastewater treatment process. Collection systems are put in place by municipal administration to ensure that all the wastewater is collected and directed to a central point. This water is then directed to a treatment plant using underground drainage systems or by exhauster tracks owned and operated by business people.

  1. Odour Control

At the treatment plant, odour control is very important. Wastewater contains a lot of dirty substances that cause a foul smell over time. To ensure that the surrounding areas are free of the foul smell, odor treatment processes are initiated at the treatment plant. All odor sources are contained and treated using chemicals to neutralize the foul smell producing elements. It is the first wastewater treatment plant process and it’s very important.

  1. Screening

This is the next step in wastewater treatment process. Screening involves the removal of large objects that in one way or another may damage the equipment. Failure to observe this step, results in constant machine and equipment problems. Specially designed equipment is used to get rid of grit that is usually washed down into the sewer lines by rainwater. The solid wastes removed from the wastewater are then transported and disposed off in landfills.

  1. Primary Treatment

This process involves the separation of macrobiotic solid matter from the wastewater. Primary treatment is done by pouring the wastewater into big tanks for the solid matter to settle at the surface of the tanks. The sludge, the solid waste that settles at the surface of the tanks, is removed by large scrappers and is pushed to the center of the cylindrical tanks and later pumped out of the tanks for further treatment. The remaining water is then pumped for secondary treatment.

  1. Secondary Treatment

Also known as the activated sludge process, the secondary treatment stage involves adding seed sludge to the wastewater to ensure that is broken down further. Air is first pumped into huge aeration tanks which mix the wastewater with the seed sludge which is basically small amount of sludge, which fuels the growth of bacteria that uses oxygen and the growth of other small microorganisms that consume the remaining organic matter. This process leads to the production of large particles that settle down at the bottom of the huge tanks. The wastewater passes through the large tanks for a period of 3-6 hours.

  1. Bio-solids handling

The solid matter that settle out after the primary and secondary treatment stages are directed to digesters. The digesters are heated at room temperature. The solid wastes are then treated for a month where they undergo anaerobic digestion. During this process, methane gases are produced and there is a formation of nutrient rich bio-solids that are recycled and dewatered into local firms. The methane gas formed is usually used as a source of energy at the treatment plants. It can be used to produce electricity in engines or to simply drive plant equipment. This gas can also be used in boilers to generate heat for digesters.

  1. Tertiary treatment

This stage is similar to the one used by drinking water treatment plants which clean raw water for drinking purposes. The tertiary treatment stage has the ability to remove up to 99 percent of the impurities from the wastewater. This produces effluent water that is close to drinking water quality. Unfortunately, this process tends to be a bit expensive, as it requires special equipment, well trained and highly skilled equipment operators, chemicals and a steady energy supply. All these are not readily available.

  1. Disinfection

After the primary treatment stage and the secondary treatment process, there are still some diseases causing organisms in the remaining treated wastewater. To eliminate them, the wastewater must be disinfected for at least 20-25 minutes in tanks that contain a mixture of chlorine and sodium hypochlorite. The disinfection process is an integral part of the treatment process because it guards the health of the animals and the local people who use the water for other purposes. The effluent (treated waste water) is later released into the environment through the local waterways.

  1. Sludge Treatment

The sludge that is produced and collected during the primary and secondary treatment processes requires concentration and thickening to enable further processing. It is put into thickening tanks that allow it to settle down and later separates from the water. This process can take up to 24 hours. The remaining water is collected and sent back to the huge aeration tanks for further treatment. The sludge is then treated and sent back into the environment and can be used for agricultural use.

Wastewater treatment has a number of benefits. For example, wastewater treatment ensures that the environment is kept clean, there is no water pollution, makes use of the most important natural resource; water, the treated water can be used for cooling machines in factories and industries, prevents the outbreak of waterborne diseases and most importantly, it ensures that there is adequate water for other purposes like irrigation.

In summary, wastewater treatment process is one of the most important environmental conservation processes that should be encouraged worldwide. Most wastewater treatment plants treat wastewater from homes and business places. Industrial plant, refineries and manufacturing plants wastewater is usually treated at the onsite facilities. These facilities are designed to ensure that the wastewater is treated before it can be released to the local environment.

Calibration for Pharmaceutical Industries

The pharmaceutical sector is governed by regulatory norms to ensure that quality standards are met for products in line with pharmaceutical cGMP guidelines. The FDA takes food and pharma production very seriously, which is why these guidelines are in place. Calibration is one such process wherein an instrument or a utility system is adjusted so that its readings are adherent to the defined guidelines. It is usually performed as per approved written procedures.
What is Equipment Calibration?
Equipment calibration is important as equipment is often used to gather critical data and hence calibrating them and keeping them up to date becomes mandatory. This process is carried out regularly since equipment used in pharmaceutical manufacturing depending on its functionality is subjected to a lot of wear and tear.Calibration is usually done component-wise to ensure accuracy of the operating equipment as per defined pharmaceutical cGMP.
Types of Calibration
Calibration types are defined as per the parameter which is crucial for a certain process. The classification is largely done on the basis of the type of reading, and common types include:
Pressure Calibration– This method calibrates pressure readings within barometers, transmitters, test gauges and other kinds of equipment commonly used in manufacturing setups.
Temperature Calibration– Calibration is done based on temperature readings, in simulation of a real-time environment. The equipment in this category includes furnaces, weather stations, bio repositories, thermistors, etc.
Flow Calibration– The calibration which is carried out routinely for flow meters that check product quantity or energy functions in processes. Some of the equipment which requires flow calibration includes flowmeters, rotameters and turbine meters.
Pipette Calibration– Pipettes are used in laboratories to measure liquids in small, precise quantities. This calibration method is utilized in labs that make frequent use of pipettes, and is a fairly stringent process since the degree of precision required is very high.
Electrical Calibration– This particular method is used for checking electrical equipment. The accreditation standards are set as per UKAS outlines, since these are considered the most accurate set of standards for electrical calibration.
Mechanical Calibration– Mechanical calibration checks for the accuracy of various measurements such as torque, mass, force, angle and vibration. All these elements are checked in a temperature-controlled facility, since variations in temperature can adversely impact the calibration process.
Since these instruments are used in real-time environments, they are subject to frequent wear and tear. However, they are used in processes that require a lot of precision in terms of data gathering and measured quantities.Therefore, in order to maintain the accuracy of the process and the measurements taken by equipment, frequent calibration is required.

The frequency with which equipment is to be calibrated depends on various factors such as:

  • The importance of the measurements for which instruments are used
  • The defined standards of the equipment manufacturer to adhere to the pharmaceutical CGMP guidelines.
  • The degree of risk involved in the process for which that equipment is being used
  • The degree of precision required from the equipment and the accuracy with which data is to be gathered from the equipment.
  • The extent to which the equipment is stable. This is evaluated from the historical data on the stability of the equipment

Calibration is a mandatory process in the pharmaceutical space considering the need for reproducible product quality. Lack of precision can lead to huge repercussions and penalties. Calibration forms an essential part of the quality assurance and validation process in the pharmaceutical industry.

Energy Audit – An Overview

Energy Audit is the first step in Energy Conservation and Energy Efficiency Projects for Industrial Plants. Energy Audit is a periodic exercise undertaken by a plant to assess its energy consumption and identify opportunities for Energy Conservation and Energy Efficiency. It also helps plant personnel in modernizing the plant with new technological solutions. It benefits plants cut down production costs.

In India, Energy Audit is quite popular in an Industrial or Commercial Facility. Many companies have realized the potential of energy saving in their plant. However one must realize that Energy Audit is only the first step in the direction of energy efficiency and energy conservation. The recommendations made as part of the energy audit have to be implemented to achieve the energy saving targets.

The energy saving recommendations doesn’t require much investment. In some high cases, the investment may be higher. The plant then takes up the investments in a phase-wise manner, which result in delayed energy saving for the plant. In fact the plant may never take some of the recommendations up. This renders the entire energy audit exercise futile.

Energy Audit works for every single Plant or Commercial Facility, as there is always scope for Energy Optimization through Energy Conservation & Energy Efficiency. Every plant goes through some changes over a period of time. Moreover an external Energy Audit team works across departments and brings in rich experience gained from Energy Audit of several plants. This not only results in gaining fresh perspective of Energy saving possibility by an external team also results in bench-marking based on similar parameters.

Energy Audit gives a positive orientation to Preventive Maintenance, Safety and Quality Control programs thereby improving the overall efficiency and output of existing system.

Nearly all the Industrial Units and Commercial Complexes have a potential to save 10-15% on Energy Bills and additional savings in Thermal Energy.

The evident reason why a plant goes for an Energy Audit is the saving of energy. This saving translates into monetary saving and hence can have a direct impact on profitability of a Company. It is also a step towards sustainability.

However, Energy Audits should look at a more comprehensive approach than just reducing cost. Industries should focus more on reducing their carbon footprint as necessitated by Governing Environmental Laws. Energy Audits must go beyond the conventional approach and adopt newer technologies for Green Power Generation.

With increased environmental awareness the pressure on Industries is mounting to reduce their Carbon footprint by adopting Greener Methods wherever possible. In such as scenario Energy Audit would play a crucial role in offering Industries a comprehensive approach towards a Greener Plant.

There is no specific answer as to how much energy a plant could save post an Energy Audit. An estimate could certainly be provided and in all cases Energy Audit could prove to be useful and economically viable. This is especially true in the present day scenario when Energy costs are ever rising and are expected to rise further.

Each Industrial Plant must carry out Energy Audits for reducing their energy usage by adopting energy conservation and energy efficiency measures.

Process Engineering: An Overview

Process Engineering focuses on design processes, operation, process control, and process optimization. This discipline of engineering may focus on physical, chemical, or biological processes. Process engineering encompasses a large array of different industries and sectors. It has a wide range of applications, considerable potential value, and diverse methods.

Process engineering, as a discipline, can be traced back to the era of the 60s, when the term was first coined. However today, this engineering field has gained popularity across the globe. Numerous companies offer Process Engineering services. It is an active area for research, study and application. Process engineering has effected positive change on a global scale.

Since Process Engineering has a broad range of applications in various industries and sectors, the specifications in analysis varies with each sector. Process engineering have various sub-disciplines. Experts usually specialize in one or two of these sub- disciplines.

Process Design – Process design looks at the way the process in question has been designed and set up. It looks for ways to improve this design and structure, and may utilize hierarchical decomposition flow sheets, attempt superstructure optimization, or study plants with multi-product batches. Poor, inefficient design and structure elements can then be removed and substituted with design components that optimize the system better.

Process Operations – Process operations looks at the way the process in question is being executed. It may incorporate real-time optimization or fault diagnosis in an effort to improve operations efficiency. It may also study the operation’s schedule and examine multi-period planning, and other relevant data.

Process Control – Process control concentrates on the reliability of the process. It often employs tools such as controllability measures, robust control, model predictive control, statistical process control, and process monitoring to name just a few. By improving control over the process more consistent, dependable results are gained.

Supporting Tools – Supporting tools in process engineering focuses on the ancillary tools and systems that help support the primary process. These tools may include things such as equation based process simulation, AI or expert systems, sequential modular simulation, global optimization, large-scale nonlinear programming (NLP), optimization of differential algebraic equations (DAEs), and mixed-integer nonlinear programming (MINLP). These supporting tools enhance the overall productivity and quality of the process.

Process engineering is beneficial to industries in various ways. They include everything from debottlenecking certain key problem areas, improving production speed, eliminating unneeded steps from a process, making the process or system safer, and increasing the quality, consistency, and/or volume of output. By and large process engineering provides a way for industries to reduce their costs while increasing the overall efficiency of their processes.

Process engineering has an incredibly far-reaching impact and potentially holds promise for nearly any industrial or commercial business. It is also at the forefront of expanding what is possible in the sciences and technology sectors. Some particular industries served by process engineering include:

  • Chemical
  • Petrochemical
  • Refining
  • Food and food processing
  • Manufacturing
  • Mineral processing
  • Medical
  • Pharmaceutical
  • Bio-techs
  • Biomedical
  • Textiles
  • Transportation

Process engineering is a fast-paced, dynamic discipline that is continually evolving and pushing the envelope of what is possible. Panorama provides a thorough professional service that covers each step of process engineering. With roots in Chemical and Pharmaceutical industry, Panorama provides the best service.

Design Of Air Cooled Heat Exchangers – Utility Optimization Services In India

Air cooled heat exchangers, often abbreviated as ACHEs, and are commonly found throughout India. Refineries and chemical plants will often use these in place of water-cooled heat exchanges – and that is because it doesn’t involve any issues regarding water, where there is shortage of water as well as pollution.

The air cooled heat exchangers are commonly referred to as air coolers, which are different from devices that cool the air, referred to as air chillers.

The overall design of air cooled heat exchangers can vary, but it involves the tube bundle where there are multiple finned tubes that terminate into a header box. The fins are made of aluminum strips and spirally wound. The fins can take on various formations, being overlapped or single. Ultimately, they are designed to provide contact resistance, which can increase based upon the temperature due to differential expansion.

Throughout India, it is important to look at utility optimization services in order to offer cooling without having to depend upon water. The country is not known for having a large amount of water to begin with, and it cannot be used within cooling units because it could take away from drinking water. Additionally, the polluted waters are incapable of being used within the heat exchangers.

The design of these ACHEs are relatively straightforward. The core tubes can be made from stainless steel or various alloys. While carbon steel is used in some instances, it is not typically found in India simply because of cost.

Air moves over the tubes in a cross flow path using axial flow fans. The way in which the air moves can be arranged in order to create induced or forced draft. This depends on what the overall goal is. Forced to draft is most common and easier to maintain. Induced draft is used for even air distribution, but requires additional power because the fans are found within the hot air stream.

As such, in order to optimize the utilities throughout India, it is most common to see a forced draft arrangement on the air cooled heat exchangers. Further, the sound is not too loud, as the principal noise is found coming from the fans. Designs can be created to reduce the noise if necessary.

The average air cooled heat exchanger is a large piece of equipment in comparison to some of the other heat exchangers, though as long as there is sufficient space, it can provide free airflow and be used in a variety of different environments.

Ultimately, the choice of design is based upon the desired ambient temperature. When temperatures rise in India, many people are glad to have these exchangers – and since it requires no dependency on water, it’s that much more advantageous to incorporate these designs into refineries, chemical plants, and various other locations.