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.

RESOURCE OPTIMIZATION

In today’s industrial age, where manufacturing processes are highly crucial and a synonym of development and growth, the need to use resources effectively and efficiently has become necessary. The continuous growth of industries has led to development of highly efficient or leaner processes which focus on minimum wastage and maximum utilization of the available resources through various technologies developed overtime. The use of robots and automating the processes in order to eliminate human error and increase efficiency has been adopted by almost every industry today which has further been facilitated by the Internet of Things (I0T) in developing smarter processes.

Utility optimization not only consists of handling resources in a smart manner, but also optimizing the path or manner in which they are handled. Adjusting the placement of machines as well as defining the flow of resources throughout the shop floor is also an integral part of the utility optimization process. An efficient flow ensures an efficient execution of process and minimum wastage of time and resources. This is usually done through the use of process flow charts do determine process steps as well as Pareto charts to determine the importance of every resource in terms of its usage and need in every process.

In order to execute resource optimization and make sure that it is continuously being carried out, energy audits and water audits can be done which track the energy needs of an organization and track the water consumption by the organization respectively. The audits not only provide feedback about the status of optimization within the organization, but also help in tracking the development in this area and accordingly set targets. Even though these audits are a bit time consuming but they are highly necessary as they help the organization stay aligned with their set targets.

Optimization of resource usage not only decreases the amount of waste generated, but also leads to greater profits and creates opportunities for recycling and reusing the wasted resources. In a lot of cases, resource optimization leads to a reduction in carbon footprint which is vital due to the currently degrading environmental conditions. Since India agreed to ratify the second commitment period (2013-2020) of the 1997 Kyoto Protocol for the reduction of Greenhouse Gases and thus reduce the carbon footprint, the need for cutting emissions and correspondingly minimizing waste through resource optimization has gained more importance. The rising trend of green technologies has facilitated in optimization as well as cutting down on energy usage and reducing emissions.

The whole world is currently progressing at an unbelievable rate and the environment is getting affected due to that very progress Resource optimization, hence, has become necessary not only for generating greater profits and minimizing wastage of resources, but also for sustainability.  “Recycle and Reuse” has become the motto for every major organization and new ways to optimize resource usage are constantly being researched and put into use. Since the progression of technology is inevitable, there will always be a great need for effective resource optimization processes which contribute to both- organization’s profits as well as sustainability.

Project Management

Project Management Institute, Inc. (PMI) defines project management as “the application of knowledge, skills, tools and techniques to a broad range of activities in order to meet the requirements of a particular project.” Project management is the discipline of using established principles, procedures and policies to manage a project from conception through completion. It is often abbreviated as PM.

Project management oversees the planning, organizing and implementing of a project. A project is an undertaking with specific start and end parameters designed to produce a defined outcome, such as a new computer system. A project is different from ongoing processes, such as a governance program or an asset management program.

The project management plan is expected to effectively and efficiently guide all aspects of a project from start to finish, with the ideal goal of delivering the outcome on time and on budget. A project plan often begins with a project charter, and it is expected to identify potential challenges in advance and handle any roadblocks as they arise in order to keep the project on schedule.

The process of directing and controlling a project from start to finish may be further divided into 5 basic phases:

Project conception and initiation- An idea for a project will be carefully examined to determine whether or not it benefits the organization. During this phase, a decision making team will determine whether the project is feasible and whether they have the resources to take on the project.

Project definition and planning- A project plan, project charter and/or project scope may be put in writing, outlining the work to be performed. During this phase, a team should prioritize the project, calculate a budget and schedule, and determine what resources are needed.

Project launch or execution- Resources’ tasks are distributed and teams are informed of responsibilities. This is a good time to bring up important project related information.

Project performance and control- Project managers will compare project status and progress to the actual plan, as resources perform the scheduled work. During this phase, project managers may need to adjust schedules or do what is necessary to keep the project on track.

Project close- After project tasks are completed and the client has approved the outcome, an evaluation is necessary to highlight project success and/or learn from project history.

Projects and project management processes vary from industry to industry; however, these are more traditional elements of a project. The overarching goal is typically to offer a product, change a process or to solve a problem in order to benefit the organization.

Responsibilities of a project manager

Business leaders recognize project management as a specific function within the organization and hire individuals specifically trained in this discipline — i.e., project managers — to handle their organization’s project management needs.

Project managers can employ various methods and approaches to run projects, generally selecting the best approach based on the nature of the project, organizational needs and culture, the skills of those working on the projects, and other factors.

Managing a project involves multiple steps. Although the terminology for these steps varies, they often include:

  • Defining project goals;
  • Outlining the steps needed to achieve those goals;
  • Identifying the resources required to accomplish those steps;
  • Determining the budget and time required for each of the steps, as well as the project as a whole;
  • Overseeing the actual implementation and execution of the work; and
  • Delivering the finished outcome.

As part of a strong project management plan, project managers implement controls to assess performance and progress against the established schedule, budget and objectives laid out in the project management plan. This is often referred to as the project scope.

Because projects often require teams of workers who do not typically work together, effective project management requires strong communication and negotiation skills. Project managers also need to work closely with the multiple stakeholders who have interests in any given project, another area where strong communication and negotiation skills are essential.

Software Validation

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity.
Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.

Software Validation commences with a user requirement document (URS). URS is prepared to describe the critical functionalities those are required for our analysis. It is essential that the document is properly scoped in order that the procurement, installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.

To scope and define an adequate validation procedure the URS has to be detailed sufficiently for various assessments to be made. The main assessment that concerns with qualification documentation is the risk assessment. This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.

So at this early stage it is required to execute a Validation Risk Assessment protocol against the end user’s requirements. This step is purely to ensure that the more obscure pieces of ancillary equipment and support services are fully understood and their requirement investigated, priced and included in the final issue of the URS; which will be sent out with the Request to Tender. This is an essential stage if the URS is to accurately define what depth and scope of validation is appropriate for the verification that the software will deliver all the requirement detailed in the URS.

The outcome of the Validation Risk Assessment (VRA) drives a split in software validation documentation scope, if the VRA categorizes the software validation as requiring Full Life Cycle Validation (FLCV); then a considerable amount of the software validation effort is put into establishing how the software originated, was designed and developed, in order to establish that its basic concept and development can be considered robust, sound and in accordance with best practices.

The original development plans; code reviews, methods reviews and testing plans must be available to enable this software validation documentation to be executed successfully. Once this proof of quality build is established, validation then follows a more convention path in inspections and verifications.

Software that is not classified as requiring FLCV treatment does not require this depth of verification into quality build history and is validated mainly by the more convention path in inspections and verifications.

Dynamic Testing

Dynamic testing verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software. Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods. One such method is static analysis. This somewhat new method largely automates the software qualification process. The technique attempts to identify errors in the code, but does not necessarily prove their absence. Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the FDA and some segments of industry recognize the value of sound verification principles and are using tools based on these principles.

Risk Based Inspection

A Risk Based Inspection (RBI) is basically a risk analysis of operational procedures. It assesses the safety risks and plant integrity that exists and further prepares it for possible inspections. The end result is a document that outlines, measures and defines organizational procedures based on standards, codes and best practices.

Generally, RBI’s are used when a company wants to change the required frequency of inspection for pressure-rate vessels. This is applicable to the mechanical integrity element of a Process Safety Management (PSM) plan.

Equipment used to process, store, or handle highly hazardous chemicals has to be designed, constructed, installed, and maintained to minimize the risk of releases of such chemicals. This requires that a mechanical integrity program be in place to ensure the continued integrity of process equipment.

Elements of a mechanical integrity program include identifying and categorizing equipment and instrumentation, inspections and tests and their frequency; maintenance procedures; training of maintenance personnel; criteria for acceptable test results; documentation of test and inspection results; and documentation of manufacturer recommendations for equipment and instrumentation.

Where there might be a bit of overlap/similarity in RBI and PSM is in the area of mechanical integrity with regard to structural engineering. Structural engineering is an important field of engineering that deals with the integrity of objects such as plant components or structures and serves the industry by performing analytical assessments, experiments, walkdowns or numerical modeling. Some companies specialize in supporting industrial process facilities and power plants.

In plants, the structural challenges are often related to pressure, temperature and dynamic forces. An example is the seismic adequacy of piping or components under power operation. Engineers perform seismic walk downs on a regular basis to screen for the seismic adequacy of systems. Several specialty engineers and contractors have undergone professional seismic training which also allows them to assess safety-related electrical components such as instrumentation and control components, etc.

Proper application of structural engineering expertise can help mitigate issues by ensuring that the plant and components are properly engineered. This will avoid machinery breakdown and costly plant outages. The goal is to support customers to achieve a safer and more efficient work environment along with enhanced plant durability.

Thus, for several aspects of RBI and PSM, an engineering firm with testing labs are ideal in providing a one-stop-resource for structural engineering issues including analyzing a problem, engineering a solution, verification, as well as oversight of fabrication and installation, as required.

Benefits to having Risk Management Services are:

  • Understand and address hazards that pose the highest level of risk to your process facility
  • Ensure compliance with relevant national, local and industry standards
  • Implement best engineering practices
  • Reduce overall level of risk
  • Increase productivity and employee morale
  • Make organization more competitive
  • Decrease insurance premiums
  • Combustible Dust Hazard Analysis (DHA) Explosion and Fire Hazard Evaluation

An onsite assessment provides an experienced engineer to visit a facility, evaluate its compliance with relevant national, local and industry standards and provide recommendations for risk reduction. Additional services can include deflagration vent sizing calculations, desktop reviews, equipment selection guidance, and training of personnel on combustible dust hazards as well as development of process safety programs to address these issues.

Risk-based inspection is a means of using inspection resources more cost-effectively and with confidence. The method ensures that you are complying with current safety regulations and also enables you to make inspection decisions informed by greater information and expertise, thereby saving time and money.

Plant operators face an increasingly complex challenge when managing the integrity of assets: to achieve operational excellence and maximum asset performance while minimizing costs and maintaining the highest safety and environmental standards.

Risk-based inspection principles offer an established methodology for efficient plant maintenance and, with Panorama’s expertise,we can work with you to develop cost-effective management solutions.

Risk Assessment

Many people interchange hazard and risk on a daily basis. Unfortunately, they are actually two different concepts. The difference may not be as much as an issue for the everyday conversation, but when it comes to risk assessment and control, it is extremely important. Below you will gain a better understanding of the difference between the two and why the difference is so important.

The basic difference is that a hazard is something that will cause harm, while a risk is the possibility that a hazard may cause harm. Although they are used synonymously, knowing the difference could save your life or allow you to enjoy it more thoroughly.

In essence, a hazard will not be risky unless you are exposed to enough of it that it actually causes harm; the risk itself may actually be zero or it may be greatly reduced when precautions are taken around that hazard.

The simple relationship between the two is that you have to have exposure to a hazard to experience a risk. Thus, it is vital that you know the level of exposure you are going to have to the hazard to better understand how much risk is actually involved.

Risk Assessment Methods

There are a variety of risk assessment methods for the various categories. When it comes to the difference between hazard and risk, several categories may use different measurements and methods. As an example, the way risk is assessed in human health may be different from the risk assessment for project management.

Why Use a Risk Assessment Method?

A risk assessment is a tool used to determine the potential results from any given hazard. The assessment uses a combination of situational information, previous knowledge about the process, and judgments made from the knowledge and information.Since the risk is the potential damage done by a hazard, there are certain outcomes that any good risk assessment needs to have.

There are six main outcomes that are needed to have an effective risk assessment. By the end of the assessment you should know:

  • Any situations that may be hazardous
  • Which method is appropriate to use when determining the likelihood the hazard will occur
  • Alternative solutions for reducing and eliminating the risk or any negative consequences the may occur
  • More information for making a decision about risk management
  • Estimation for the uncertainly of the analysis

Steps of a Risk Assessment

Step 1: Discover the hazards. You can do this by using several different strategies such as walking around the area, navigating through portfolios and databases, or asking people who are around.

Step 2: Determine who may be harmed and how they may be harmed. After discovering the hazards you will need to determine who may be harmed by them, as well as how they may be harmed.

Step 3: Analyze the amount of risk and how you can control them. You may find that you can simply remove the hazard. If not, then decide which control method will be best to use to reduce the amount of risk.

Step 4: Document your assessment and results. It is important that you document what you find. This is done for legal reasons to protect you, the location, and any possible persons that may be involved. You also want to be sure that you write down your next plan of action – what control measures you are going to take.

Step 5: Regularly review and update your assessment. It is great to think that once the hazard is gone that all risks of harm are gone. This is not true. In some cases the hazard may return and in other new hazards may develop. Regularly checking will keep you and everyone around safe.

Risk Control Methods

Knowing the difference between hazard and risk leads to risk control. Risk is controlled when your business takes actions that help eliminate safety risks as much as you are able to do so. If it is not possible to completely eliminate the risk, controlling your risk may mean that you are taking actions to minimize the risks and hazards within the work environment.

There are four main methods that can be used to eliminate or minimize these risks – avoidance, loss prevention & reduction, transfer, and acceptance.

1. Avoidance

This is by far the easiest way to control any risk. When you decide to use this method, you find all possibly hazardous activities and stop them. It is important that you remember when choosing this option you may also miss out on other opportunities and gains.

2. Loss Prevention & Reduction

Using this method you will reduce the frequency and severity of a specific loss. You may decide to increase security measures or improve maintenance, or you may create rules that require your employees to wear certain safety gear.

3. Transfer

When you choose this method you will create a contract with a third party to deal with that risk. A couple great examples would be hiring a security company to improve security or hiring a cleaning crew to ensure health hazards are cleaned up.

4. Acceptance

This last method is not to be taken lightly. When you feel that transfer or loss prevention & reduction methods are not necessary or are too excessive, this may be the option for you. However, it is important that you understand this could possibly be dangerous for your company. Undergoing too many losses or enduring too many negative consequences can quickly sink your business.

What is Zero Liquid Discharge?

Zero Liquid Discharge (ZLD) is a wastewater treatment process developed to completely eliminate all liquid discharge from a system. The goal of a zero liquid discharge system is to reduce the volume of wastewater that requires further treatment, economically process wastewater and produce a clean stream suitable for reuse. Companies may begin to explore ZLD because of ever-tightening wastewater disposal regulations, company mandated green initiatives, public perception of industrial impact on the environment, or concern over the quality and quantity of the water supply.

The first step to achieving ZLD is to limit the amount of wastewater that needs to be treated. Once wastewater generation is minimized and the volume of wastewater that needs to be treated is known, you can then explore what equipment is needed, which depends on the characteristics of the wastewater and its volume. A traditional approach to ZLD is to use filtration technology, funnel the reject waters to an evaporator, and send the evaporator concentrate to a crystallizer or spray dryer. However, the equipment to de-water the concentrated slurry tends to be very large and extremely expensive, which limits the cost effectiveness to only those with very large waste streams.

A common ZLD approach is to concentrate the waste water and then dispose of it as a liquid brine, or further crystallize the brine to a solid. A typical evaporator uses tube-style heat exchangers. The evaporated water is recovered and recycled while the brine is continually concentrated to a higher solids concentration. Concentrated brine is disposed of in a variety of ways, such as sending it to a publicly owned treatment works, using evaporation ponds in areas with net positive evaporative climates, or by treatment in a crystallizing system, such as a circulating-magma crystallizer or a spray dryer. Crystallized solids can be landfilled or applied to land, depending upon the crystal characteristics.

For over 30 years vapor compression evaporation has been the most useful technology to achieve zero liquid discharge. Evaporation recovers about 95 % of a wastewater as distillate for reuse. Waste brine can then be reduced to solids in a crystallizer/dewatering device. However, evaporation alone can be an expensive option when flow rates are considerable. One way to solve this problem is to integrate membrane processes with evaporation. These technologies are nowadays often combined to provide complete ZLD-systems.

The most common membrane processes used so far are reverse osmosis (RO) and electrodialysis reversal (EDR). By combining these technologies with evaporation and crystallization ZLD- systems have become less expensive. They are however combined differently depending on the circumstances. Together with these components, a variety of other well-known water treatment technologies are used in ZLD-systems for pre-treatment and polishing treatment.

These treatments are:

  • pH adjustment
  • Degasifier
  • mixed/separate bed
  • oil/water separator
  • neutralization
  • oxidation (uv , ozone, sodium hypochlorite)
  • dissolved air flotation (daf)
  • carbon adsorption
  • anaerobic or aerobic digestion

As environmental, political and public health entities place more focus on waste water management, ZLD strategies are more often being evaluated for feasibility in industrial facilities. The ZLD approach taken, however, greatly depends on the quality of water available for use.

ZLD benefits:

  • Reduction or elimination of costly regulatory compliance
  • Reliable chemical/physical processes
  • Small footprint
  • Ease of operation
  • Almost 100% water recovery
  • Almost 100% metals and chemical recovery
  • Modular construction
  • Low costs

Well-designed ZLD system will minimize the volume of liquid waste that requires treatment, while also producing a clean stream suitable for use elsewhere in the plant processes.

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.

Good Automated Manufacturing Practice for Pharmaceutical Industries

The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by pharmaceutical industry professionals in the United Kingdom to address the industry’s need to improve comprehension and evolving expectations of regulatory agencies in Europe. The organization also sought to promote understanding of how computer systems validation should be conducted in the pharmaceutical industry.

GAMP rapidly became influential throughout countries as the quality of its work was recognized internationally. Over time, GAMP has become the acknowledged expert body for addressing issues of computer system validation.

GAMP’s guidance approach defines a set of industry best practices to enable compliance to all current regulatory expectations. More than simply a strict compliance standard, GAMP is a guideline for life sciences companies to use for their own quality procedures. As a result, it can be tailored to a number of computer system types.

Computer system validation following GAMP guidelines requires users and suppliers to work together so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance that a system is appropriate for the intended use before it goes live. Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality product leaves the facility.

The GAMP framework addresses how systems are validated and documented. Companies do not need to follow the same set of procedures and processes of a GAMP framework to achieve validation and qualification levels that satisfy inspectors. Instead, GAMP examines the systems development lifecycle of an automated system to identify issues of validation, compliance and documentation.

As a voluntary program, GAMP offers both challenges and benefits. The top three challenges in implementing GAMP are establishing procedural control, handling management and change control, and finding an acceptable standard among the existing variations.

Establishing procedural control is a challenge in using GAMP guidelines because new frameworks may be necessary to gauge the validity of systems. Most pharmaceutical companies have already established a baseline that adheres to standards and regulations that exist today, but they may not have a procedure to check the processes that are in place. This could cause resistance among software developers who may prefer not to work within the confines of specifications and procedures developed by others. Specifications and procedures developed by previous software developers may hinder ways to adjust computer systems, but varying interpretations of GAMP guidelines allow for multiple solutions.

Another hurdle is change control. In the development or modification of computer systems, companies with even the highest of standards can suffer setbacks along the systems development lifecycle. Sometimes minor tweaks by the software programmer may cause breakdowns after validation changes have been implemented. Internal processes and procedures must be established to guard against these occurrences.

Effective documentation management is fundamental for compliance. Any inaccuracies or missing information renders all other efforts moot. Moreover, implementing a formal document management application may be cost-prohibitive for some organizations. Some companies simply use what’s in the GAMP checklists to evaluate their systems. Today’s environment demands a thorough process to show validation.

The benefits of utilizing the GAMP approach for both users and suppliers include:

  • Improved understanding of the subject with the introduction of common terminology
  • Reduced cost and time to achieve compliant systems
  • Reduced time and resources for revalidation or regression testing and remediation
  • Reduced cost of qualification
  • Enhanced compliance with regulatory expectations
  • Established responsibility for all involved parties

When the FDA introduced its current Good Manufacturing Practices (cGMP) for the 21st century initiative, companies shifted their approach to validation. Formerly, they only had to heed a set of rules that accounted for every piece of equipment that was used. Now they can take a risk-based approach to validation by addressing safety, efficacy and quality in the product considerations. This enables the industry to place its investments where it makes the most sense. The onus ultimately falls on manufacturers to accept greater responsibility to validate their systems having the attendant benefits of cost and time to market savings.

GAMP helps provide a quality product from the manufacturer, and helps to limit the pharmaceutical industry’s culpability by ensuring proper steps were placed to deliver a quality product through validated systems. By incorporating input from the full spectrum of stakeholders, fine-tuning and further development of the process is geared towards benefiting the life sciences industry and the general consumer market.

The tools exist for companies to take the steps needed to reap the benefits of validation. Understanding an early adoption of GAMP can increase a company’s competitive position, especially with the implementation of new technologies. By staying aware of technological innovations, companies are able to increase efficiency, minimize risks and reduce costs.

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.