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.

Automated manufacturing Practice

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.

Plant Design

Plant design & engineering

From conducting Feasibility studies, FEED / Basic & Detail engineering during the engineering phase to providing field engineering services during construction & commissioning, a plant design & process engineering company & its services should span across the entire life cycle of projects.
Typical list of services covered under plant design & engineering include:

  • Conceptual and Techno-Economic Feasibility Studies
  • FEED & Basic Engineering
  • Pre-bid / Proposal Engineering
  • Preparation of Process Packages
  • Technology and Process Licensor Selection
  • Detailed Design & Engineering
  • Procurement & Construction Support
  • Field Engineering
  • De-bottlenecking studies and Trouble Shooting
  • Laser Scanning and 3D modeling
  • As-Built documentation
  • Decommissioning Studies

A company involved in process management & plant engineering carries out all the above activities. All the phases have to be carefully managed starting from Engineering Execution Strategy the FEED and defining the project baseline standards by establishing the codes to and procedures to be able to set Engineering Audit.

A plant design & engineering company has to maximize energy output and reduce LCOE. Since every project is different, Project specific factors such as the local irradiance, weather, soil, wind, and topography must be taken into account for the design, layout, technology selection, and system configuration.

By utilizing the plant design & engineering company’s industrial applications, facility owners will be able to more efficiently implement and execute the challenging plant design management processes.
Why Panorama as your plant design & engineering firm?

Panorama’s Plant Engineering team includes highly experienced engineers in the design and maintenance of industrial processing plants.

Our primary customer groups are those who are in the business of processing, refining, handling, manufacturing or treating petrochemicals, gases, water, waste, bulk materials, minerals, food products or manufactured products for use in other processes or for sale to others.

If you are looking to either expand your business, increase production, reduce bottlenecks, manufacture new products, improve efficiency, upgrade to new technologies, refurbish or repair – Panorama’s offering ranges from machine engineering and finite element analysis to fully integrated, multi-discipline industrial plant design.
Panorama utilises the latest 3D modelling software for each phase of project design development, from conceptual to definitive design, right through to the production of documentation for construction.

Panorama also customizes our delivery to suit the industrial plant company’s project development strategy – becoming accustomed to roles in a wide range of contractual relationships including: due diligence, design consultancy, independent inspection, EPCM, EPC, D&C, owner’s engineer, and strategic alliances.

Read more on what are the steps involved in Industrial Plant Design

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.