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Good Manufacturing Practices: Sterile & Aseptic Processing

Key areas of focus

Whenever we talk about a greenfield pharma facility, GMP and its compliance have always been in discussion. Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing in an efficient and effective manner is necessary for pharmaceutical manufacturing facilities and labs. Today, as regulatory expectations evolve and technologies advance, staying aligned with modern interpretations of cGMP guidelines is more critical than ever. This article throws light on how small to mid-sized manufacturing facilities can achieve compliance by adopting simple, cost-effective methods.

Why is compliance to cGMP so important?

While practicing GMPs ensures a safe, efficacious, and high-quality product that protects the end-user — the patient — it also ensures that the risk of contaminating the product is reduced or detected and controlled quickly. This, in turn:

  • Maximizing operational efficiency
  • Eliminating wastes
  • Improving organization’s bottom line

STERILE & ASEPTIC PROCESSING

With the latest CGMP guidelines emphasizing risk-based approaches and data integrity, staying compliant also means staying competitive.

What equipment does the facility rely on when coordinating aseptic/sterile processing activities?

Many alternative automated methods can replace traditional approaches that pose a risk of non-compliance with GMPs. As far as possible, equipment fittings and services should be designed and installed so that operations, maintenance, and repairs can be carried out outside the clean area. Equipment that must be taken apart for maintenance should be re-sterilized after complete reassembly, wherever possible.

Today, smart sensors, AI-enabled monitoring systems, and integration with building automation systems (BAS) have become integral to achieving real-time GMP compliance. These are especially relevant in pharmaceutical engineering where efficiency, safety, and traceability are crucial.

What are the best practices for manufacturers to improve/enhance their aseptic/sterile processing activities?

A further way of enhancing aseptic/sterile processing is to reduce risk through automation. A particularly critical unit operation during biomanufacturing is the final filling of the drug product. To this end, equipment such as an automated vial filler and capping unit could be used to provide an aseptic environment and control of process steps.

Day-to-day improvements to workflows are easily achievable through implementing more automation in the microbiological quality control lab. This speeds the time to result of many assays, creating higher throughput in the lab’s general operation. It also reduces staff stress and anxiety by minimizing the chances of error, the need for retests, and the potential burden of performing investigations for root cause. These factors alone can greatly improve the overall value, utility, and employee satisfaction in an organization.

With shift toward Industry 4.0, integration of digital twins and modular automation is becoming the gold standard for aseptic processing. EPC companies with domain expertise are leading the way in helping manufacturers embed these innovations effectively.

How can Pharma Access help new organizations (e.g., small start-ups), specifically on how to practice and comply with GMPs?

Startup organizations often mistakenly feel they don’t have the expertise or capacity to implement rapid methods in the beginning and rely on the comfort of traditional methods. However, they fail to realize that as a startup, they have the perfect opportunity to innovate and use modern methods right from the start, rather than try to overcome inertia later. Investing time to gain the knowledge and experience of using the best available methods early on will set up startups for success in the long term.

Using rapid, alternative methods not only ensures GMP compliance from day one, but also ensures successful business operations by optimizing production, improving product quality, and reducing risks.

For new companies, there are a number of ways to comply with GMP regulations. The increasing use of pre-sterilized systems such as single-use assemblies offers several advantages:

  • No cleaning validation
  • Easy product changeover (ideal for multi-product facilities)
  • No risk of cross-contamination

Additionally, digitized validation protocols, paperless documentation systems, and centralized compliance dashboards are reshaping how startups handle CGMP requirements.

Working with a reliable and trusted partner like Pharma Access — with a deep understanding of pharmaceutical engineering and experience in engineering consulting — ensures that revalidated components are easily incorporated into processes. We also provide effective support and verification of your supply chain.

At Pharma Access, we bring deep expertise in GMP compliance documentation, supporting both greenfield and brownfield pharmaceutical projects. As an experienced EPC partner, we work closely with you to design and build facilities that are compliant, efficient, and ready for future growth.

Reach out to us at sales@pharmaaccess.net or visit www.pharmaaccess.net to learn how we can support your next project.

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Achieving Sustainability Through Zero Leakages in Manufacturing Facilities

Achieving Sustainability Through Zero Leakages in Manufacturing Facilities_Pharma Access Guide.

Leakages in a manufacturing facility are more than just a minor inconvenience—they can lead to significant financial losses, environmental concerns, and operational inefficiencies. For industries like pharmaceuticals, where precision and efficiency are paramount, eliminating leakages is not just a goal but a necessity for sustainable operations. Leading pharmaceutical consulting companies emphasize the importance of a well-engineered facility to minimize such risks and ensure long-term efficiency.

The Impact of Leakages on Sustainability

Leakages can drain resources and contribute to environmental pollution, making sustainability efforts difficult. While companies often focus on reducing accidents to zero, achieving zero leakages is equally possible with strong leadership commitment. An effective zero-leakage facility provides multiple benefits, including:
• Material Conservation – Reducing waste and optimizing resource usage.
• Emission Control – Minimizing pollutants released into the environment
• Pollution Reduction – Ensuring cleaner air and water.
• Fire and Explosion Prevention – Mitigating safety hazards linked to gas and steam leaks.
• Increased Productivity – Preventing disruptions and improving overall efficiency.
• Reduced Forced Shutdowns – Avoiding production halts due to system failures.
• Lower Batch and Cycle Time – Enhancing process efficiency.
• Improved Workplace Environment – Eliminating unwanted odors and noise pollution.

The Hidden Costs of Leakages in Pharmaceutical Facilities

In context of Pharmaceutical industries, most leakages are often observed in compressed air, steam, laboratory gases in good maintained facility and these are very costly utility every facility uses. Study suggest that in average a facility encounters about 200 leakages in a year which can be segregated as following.

A common leakage observed in almost all pharma facility is compressed air from valve spindles, pipes, welding, temporary joints, PU tube connection etc. accompanied by irritating hissing noise.

A 2mm hole at 6 bar pressure can cost a facility above Rs200,000/ year. (USD2400/ year). Similarly, a with a 5mm leakage on steam line with 3 bar g operating pressure can emit 23.67 kgs/hr. steam which could cost annually about Rs 850,000 per annum or USD 10365/ annum.
• 1-2% as major and requires force shutdown.
• 2-4% as serious and requires high repair cost
• 5-10% as minor with certain damages
• Other 85% are losses facility management does not effectively monitor and consider those as uncontrollable at times.

The Hidden Costs of Leakages in Pharmaceutical Facilities

Effective Measures to Achieve a Zero-Leakage Facility
Leakages are preventable, and management must take proactive steps to mitigate them. Engaging with engineering consulting services can help develop a structured approach to achieving leak-free operations. Here are some key measures:
1. Zero Leakage as a Policy, Not an Option
Commitment from top management is crucial. Zero leakage should be embedded into corporate policies and operational goals.

2. Design and Installation Considerations
Studies show that 80% of leakage issues stem from poor design, improper component selection, and incorrect installation. Collaborating with epc companies specializing in pharmaceutical manufacturing ensures high-quality materials and precise installation to prevent future losses.

3. Life Cycle Costing Approach
Facilities should evaluate long-term operational costs while selecting equipment rather than opting for cheaper, short-term solutions.

4. Frequent System Audits and Monitoring
Regular inspections and audits help identify hidden leakages. Monitoring tools and automated detection systems can significantly improve leakage management.

5. Translating Losses into Financial Terms
By quantifying leakage-related losses in monetary terms, organizations can drive accountability and encourage continuous improvement.

Conclusion

Leakages are not an inevitable part of facility operations—they are preventable with the right strategy, investment, and commitment. Implementing a zero-leakage policy can save money, enhance sustainability, and improve operational efficiency.

For pharmaceutical and other manufacturing industries, eliminating leakages is a vital step toward achieving environmental responsibility and long-term profitability.

Is your facility prepared to achieve zero leakages? The time to act is now!

How Pharma Access Can Help

At Pharma Access, we specialize in designing and implementing leak-proof, sustainable manufacturing facilities. With our expertise in engineering consulting, EPC (Engineering, Procurement and Construction) projects, and project management consulting services, we provide innovative solutions to optimize your facility’s performance and sustainability.

Our unique approach, ENGICUTION (Engineering + Execution)—a seamless integration of engineering and execution—ensures that every project meets the highest standards of quality, efficiency, and compliance. By combining precise planning with flawless execution, we help clients achieve operational excellence with minimal risk and maximum sustainability.

Contact us today to explore how we can help you achieve a zero-leakage facility and enhance your operational efficiency.

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Sustainable Facility Design: Boiler Efficiency Optimization in Process Industries

Boiler-Efficiency-Optimization-in-Process-Industries

Boilers play a critical role in process industries, especially in pharmaceutical facilities, where steam or hot water generation is essential for heating applications. However, fossil fuel consumption in these systems is significant, leading to increased energy costs and environmental concerns.

Combustion heat loss is one of the biggest sources of inefficiency in boilers. Modern boiler systems typically operate with efficiency levels between 65% and 85%, as measured by indirect heating efficiency calculation methods. with growing pressure to reduce energy consumption and carbon footprints, organizations are increasingly focusing on strategies to improve boiler performance.

The connection between boiler efficiency and environmental sustainability is clear: improving efficiency directly leads to lower fuel consumption, which in turn reduces CO₂ emissions, contributing to cleaner and more sustainable operations.

What is Combustion Efficiency?

Combustion efficiency is a key indicator of overall boiler performance. It depends on the correct air-to-fuel ratio, which ensures complete combustion. In an ideal scenario, air and fuel mix in their exact stoichiometric proportions—the precise mass of air required to fully combust a given amount of fuel.

Practical Challenges

Achieving perfect stoichiometric combustion is practically impossible due to:
a) Imperfect burner mixing capabilities – Burners may not mix air and fuel evenly.
b) Excess air requirements – Boilers often need more air than the stoichiometric amount to ensure complete combustion.
These challenges often lead to two common scenarios that affect boiler efficiency.

The Excess Air Dilemma
When managing combustion, balancing air supply is crucial. Two key issues arise:

a) Insufficient Air: Leads to incomplete fuel combustion, causing:
– Reduced heat output
– Increased carbon monoxide (CO) emissions
– Potential regulatory non-compliance

b) Excessive Air: Leads to efficiency losses through:
– Heat loss through flue gas
– Reduced combustion efficiency
– Unnecessary energy waste

Optimization Strategies for Boiler Efficiency

I. Oxygen Content Management
Monitoring and regulating flue gas oxygen levels can significantly improve boiler efficiency. Modern combustion control systems use oxygen trimming mechanisms with the following recommended parameters:
– CNG/LPG systems: 2% oxygen content (~15% excess air)
– Oil-based systems: 3% oxygen content (~20% excess air)

2. Consideration of Operating Conditions
– High-fire operation: Maintain standard oxygen levels.
– Low-fire operation: Requires increased oxygen levels (6-7%) to sustain stable combustion.
– Efficiency impact: Every 5% increase in excess air results in a 1% efficiency loss.

3. Advanced Control Systems
While oxygen monitoring is a cost-effective solution, its effectiveness decreases in certain conditions, such as:
– Low-fire operations
– Low ambient air temperatures

To address these limitations, modern control systems incorporate carbon monoxide sensors instead of oxygen sensors. The benefits include:
– More effective excess air elimination
– Improved control over unburnt fuel
– Enhanced regulatory compliance
– Better performance across varying operational conditions

    Economic and Environmental Impact

    Adopting advanced combustion optimization systems can provide both environmental and economic benefits, making it a win-win solution for industries.

    1. Cost Savings
    Investing in boiler efficiency optimization can yield substantial cost savings. For example, an industrial facility with an annual fuel cost of $1,000,000 can achieve:
    – A 1% efficiency improvement, resulting in $10,000 annual savings
    – Reduced maintenance and operational costs

    2. Environmental Sustainability
    – Lower CO2 emissions contribute to a reduced carbon footprint.
    – Enhanced ESG (Environmental, Social, and Governance) scores for businesses.
    – Compliance with evolving government regulations on emissions control.

    Current Industry Status and Adoption Trends
    Many industries in India still rely on traditional control systems without oxygen or carbon monoxide trimming capabilities. The integration of advanced control technologies in boilers can deliver substantial advantages, including:
    – Improved Industrial Operations: Enhanced performance and reliability across varied conditions.
    – Regulatory Compliance: Staying ahead of stringent environmental standards.
    – Environmental Sustainability: Reduced fuel consumption and carbon footprint.
    – Cost Efficiency: Significant savings in operational expenses.

    Why You Should Invest in Boiler Efficiency Technologies?

    Incorporating advanced boiler efficiency technologies—such as high-performance burners and oxygen/carbon monoxide control systems—into industrial operations not only enhances environmental sustainability but also ensures long-term cost savings. These systems help organizations meet regulatory standards while achieving optimal performance, which leads to:
    – Reduced fuel consumption
    – Lower emissions
    – Enhanced operational reliability

    Investing in these systems represents a forward-thinking approach that aligns with modern business goals of cost optimization and environmental responsibility. The result? A sustainable and efficient industrial operation that’s ready for the challenges of tomorrow.

    Why Pharma Access?

    At Pharma Access, we specialize in EPC solutions for pharmaceutical turnkey projects, helping industries design and optimize their pharmaceutical manufacturing facilities for enhanced efficiency and sustainability. Through our unique approach—ENGICUTION (Engineering + Execution)—we bridge the gap between precision engineering and flawless execution, ensuring your operations are:
    – Cost-effective
    – Regulatory compliant
    – Environmentally responsible

    With our expertise in engineering consulting services we provide customized solutions that drive energy efficiency and sustainability.

    Ready to optimize your facility’s energy efficiency? Let Pharma Access take your operations to the next level. Contact us today to learn how our expertise in boiler efficiency optimization can drive sustainability and cost savings for your business.

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    Lifecycle Costing & Capital Budgeting

    Life cycle costing is the process of assigning all costs that the owner of an asset will incur over its lifespan from acquiring the asset to get rid of the asset. These costs include the initial investment, operation and maintenance cost, cost of poor quality (COPQ) interest on investment, minus any salvage value at the end of life of asset.

    Return on Investment (ROI) should be the criteria for evaluating the asset based on Life Cycle Costing (LCC) and Overall equipment Effectiveness (OEE) not merely on the capital cost and output parameter. Often capital investments are done considering the asset cost and the output parameters likes volumes / hour, but we forget to account for energy cost, environment impact cost, quality cost (COPQ) operation personnel cost, maintenance cost etc which are part of operational cost.

    A study by Carbon Trust mentioned that for an Air compressor, a common asset used across industries for a 10-year life span the energy cost is 73%, capital cost is 18% maintenance cost is 7% and installation cost is 2%. So only basis of the capital cost and output without looking at the energy cost and maintenance could be a wrong decision.

    Life Cycle Cost

    Similarly, for industry asset OEE is very critical which is a KPI of plant productivity that bring efficiency to operation. OEE of an asset depends on the availability ratio (A), Quality ratio (Q) and performance ratio.

    • Availability Ratio – The share of the actual production time and the planned production time. All planned stops and breakdowns will reduce the availability ratio, including set up times, preventive maintenance, breakdowns and lack of operators. The only time that you may choose to deduct from the availability ratio is lack of orders.
    • Performance Ratio – Loss of production due to under utilization of the machinery. In other words, losses are incurred when the equipment is not run with full speed. Short, unregistered, stops may affect the performance ratio as well.
    • Quality Ratio – The amount of the production that has to be discharged or scrapped.

    All the three ratios are important for taking decision on LCC. Let us discuss each parameter in terms of LCC.

    Availability ratio:
    If the asset is on reliable, breakdown frequently may be due to hardware or software issue then the availability of the asset reduces to the planned run hours. This will impact the overall output planned Service support from the asset supplier is very important. Many a times it is observed that due to poor service support asset remains under unavailable condition to operation.

    Performance Ratio:
    When the asset is under utilized or when it is not run to its full capacity the performance ratio reduces and that impact the productivity.

    Quality Ratio:
    Asset are supposed to make 100% acceptable quality product but due to inherent design property they produce rejected product as well. The more the reject the less the productivity.

    The Lifecycle Cost Curve

    Let us take one example to understand the effect of OEE on LCC for an asset which is operating at 90% availability, Performance at 93% and quality at 91% verses a higher capital cost but better A, P&T of 95%, 98% and 97%.

    OEE of Asset with Low capital cost A x P x Q = 0.90 x 0.93 x 0.91 = 0.76 (76%)

    OEE of Asset with higher capital cost= A x P x Q = 0.95 x 0.98 x 0.9 = 0.83 (83%)

    Therefore, we can see 7% improve in overall effectiveness or productivity which is substantial and should be considered as an evaluation criterion of asset.

    The life cycle costing estimates help in the decision making process where the mutually exclusive option is available. As shown in the above figure it is a trade-off between operating cost and capital or installed cost of the asset. Also, the management can plan on how to reduce the overall cost of the item through the extension of useful life, efficient utilization, or other similar cost.

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    Upcoming Multiproduct Facility in North Africa

    Project Fact Box

    Forms:

    • Oral Solid Dosage (Tablets, Capsules)
    • Oral Liquid Dosage
    • Ointments

    Total Project Area: 4,015 sqr. Mt

    Pharma Access Scope:

    • Heating Ventilation & Air Conditioning
    • Building Management System
    • Access Control System

    Our Value Additions

    • Accurate designs with the use of Revit 3D models
    • European makes for modern automated systems
    • Scheduling, Tracking, monitoring & reporting of the project plan
    • Efficient and compact design for HVAC
    • Pre installed skids installed to save up on execution time

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    Turnkey Project for Aseptic Facility in Tunisia

    Project Fact Box

    Forms:

    • Vial Line for Paracetamol

    Total Plot Area: 9,800 sqr. Mt

    Pharma Access Scope:

    • Engineering Studies
    • Equipment & Batch Sizing
    • Supply of equipment & systems
    • Site Execution

    Timeline:

    • November 2019 to May 2020

    Our Value Additions

    • One of the biggest facility of vial of 100ml & 50 ml paracetamol which required huge space in linear operation, however we designed in U shape operation
    • Recipe driven validated system for Formulation compounding (5000 Ltr batch size)
    • Fully Automatic Integrated line from vial washing – Depyrogentation – Filling – Capping and secondary packing
    • Complete integration of Formulation compounding and filling including online CIP + SIP
    • Formulation and Filling are compliant to 21 CFR part 11
    • Economical method of terminal sterilizing of filled vials designed, supplied & successfully installed

    Electrical stacker is provided for tray loading for Autoclave carriage

    Automated & Synchronised Systems

    Advanced Facility designed for Continuous Operation

    GMP Compliant Designs with High OEE

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    New Paradigms for Validation for Industry 4.0

    What is Validation for Pharma 4.0?

    A fundamental cGMP requirement is that systems, processes & methods which are used to manufacture medicines are validated, meaning their fitness for purpose is demonstrated. For success in Industry 4.0 in the pharma space, the manufacturers need to transition from the old ways of approaching compliance & embrace this new age of data-powered technology.

    Let us discuss how can we shift our mindset for achieving Validation 4.0

    Transitioning from the Traditional Ways

    For Validation 4.0, we need to move on from creating historical documents of what was tested to focus instead on real-time verification of product quality by managing specification and evidence data around a process that is in a state of control throughout the life cycle. Standalone documents are clearly not suited to continuous verification, and the masses of documentation created by both suppliers and regulated companies in the name of validation are inefficient, difficult to maintain, and perhaps not auditable.

    Digital artifacts managed with appropriate tools can instantaneously provide reporting and notifications on the state of control. The systems used widely today by agile software developers for cloud solution providers are a good reference point for Validation 4.0 to leverage and integrate quality management efforts into our ongoing activities of continuous verification beyond what is possible with static documented evidence.

    Data – The Foundation

    Data integrity has been a buzz term for years now. A whole subindustry has been built around this concept, and yet we still fail to truly embrace what it means and how to implement it. Data is the foundational element of validation and the basis for decision making. When we consider validation, we need to shift our focus to how we control the data that allows us to make GmP decisions and look at validation under a QbD lens.

    The focus of validation changes from qualification testing to ongoing and constant assurance that the needed controls are in place and operating correctly. This continuous verification of the process and risk is the primary evidence that the process is in a state of control. By using real-world data to feedback into our process, data, and risk evaluation, we can be assured that our products are constantly manufactured and released based on sound data, and through this model, we can continuously reassess risk conditions and handle inherent process variability.

    Majority of the pharma giants have already begun the use of data architecture which includes data warehousing, data marts, data mining for checking the effectiveness of each dosage on their patients, collecting and analyzing medical report (pathological) of person undergoing test to facilitate R &D, manufacturing, supply chain.

    Transitioning from Validation to Validation 4.0

    As per US FDA, “effective process validation contributes significantly to assuring drug quality”. Process validation is a series of activities that occur over the life cycle of the product.

    Validation Life Cycle

    While process validation covers and takes care of the following things:

    • Create quality target product profile
    • Identify CQAs
    • Define Critical Process Parameters
    • Evaluate the process to verify that it can reproduce consistent & reliable levels of quality
    • Detect & resolve process drifts

    Validation 4.0 covers these aspects:

    • Holistic planning & design.
    • Conduct process and data flow risk assessment at the design stage, incorporating criticality and vulnerability to define the control strategy, and to implement data integrity as a fundamental aspect of QbD.
    • Automate to rapidly ensure that planned controls are in place / effective.
    • Incorporate data from across the value chain (from raw material suppliers to patients) and product life cycle to evolve the control strategy into a holistic control strategy.

    Conclusion

    By moving to a process and data-centric approach to validation, and finally establishing a baseline for incorporating QbD, the pharma industry can move to continuous assurance of product quality throughout the product’s life cycle, and at every point in time.




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    Energy Efficiency in Pharma Engineering!

    How can Pharma Access Help?

    Marginal changes in production setup can result in significant energy savings!

    Shifting from Batch -> To Continuous Manufacturing

    20 – 30% Savings!

    Recycling residual steam & clean water

    10% Savings!

    Shifting from Open -> To Closed Manufacturing

    8 – 10% Savings!

    Upgrading WFI with membrane technology

    8 – 10% Savings!

    Optimizing Equipment

    5 – 10% Savings!

    Our Subject Matter Experts are here to help you find ideal sustainable solutions for your Pharma facility!

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    Value Engineering for Sustainable Facilities

    • Value Engineering for Sustainable Facilities

    Cost is what you pay for the product and Value is the worth you get for the cost you pay. Cambridge Dictionary defines value engineering as it is the process of reducing the cost of producing a product without reducing its quality. Quality Guru Philips Crosby define Quality as fitness for use. In his best seller “Quality is Free” that brought quality revolution to industry, Crosby advocated about the zero defect product. According to him every penny you do not spend on doing things wrong, over, or instead of, becomes half a penny right on the bottom line. If you concentrate on making quality certain, you can probably increase your profit by an amount equal to 5 to10% of your sales. That is a lot of money for free.

    In other word any part or component which is not required for proper functioning of the product should be consciously eliminated and focus on improving the quality and reliability of component / system desired by the end user. While eliminating the functions / component and system the following questions should be asked.

    • Does this elimination would affect the law of land (statutory & regulatory)
    • Is my customer ready to pay extra for this?
    • Are there any alternatives that improves the design & price without altering the customer requirements?
    • Can we avoid the component / parts / systems?

    The above statement just does not apply to product / system it is also applicable to services also or business processes where we apply that consciously to improve it.

    Customer will be delighted if we can place all our product / process / services in the low-cost high value category from other three quadrant. The probability is always high when the product in design stage.

    In our day-to-day activities we come across many where consciously if selected the value of the product / processes or services can be improved. Often, we follow the processes and procedure without questioning why only in the consideration that what is working well shall work well and with that attitude we do not improve or bring efficiency to system. For example, in pharmaceutical water (Water for injection, WFI) storage tank is fitted with a spray ball. Is it necessary when hot WFI at 80 Deg C are circulated in the tubing? When the pressurized water falls on the atmospheric tank at 80 Deg C it becomes steam and sanitize the tank top then wetting of tank top is not necessary by spray ball rather it increases the pressure drop in the loop and increase the operating cost 24 hrs 365 days basis.

    Similarly, the loop return velocity at 1.2 m/s minimum does not have a firm basis where 1m/s is good enough. By increasing the return velocity, we not only increase the pumping cost but also reduce the availability of water to user point and elevates rouging and its treatment cost. Do we really require 316l EP tubes for pure steam? These are just few examples but based on the project we can drill down to each activity of a project let it be water system, HVAC, utility we can find many things being practices without a logical background and thereby increasing the capital and operational cost.

    Sometime it is true that we consider too much for future that compel us to consider so many functions which is not required for the project. Every project has a success criterion, and we must focus on that and if project success criteria mentioned about those requirement, then it is must to consider other wise at best you should consider to provide the minimum flexibility so that changes is possible at a later date through another project criteria. Once a project criterion is finalized, we must work on that to make the project successful at a better cost, quality and timeline that ultimately improves the business.

    Value engineering is not cutting the cost, but a systematic effort to minimize cost to improve the value Once the facility design is at an acceptable level, value engineering session should be carried out along with all SMEs and consultants to improve the project quality (scope), cost and schedule so that the project success criteria is met at a reasonable cost and time This exercise at design level has the potential to reduce the cost and time by minimum 10% if thoughts are applied consciously.

    We, at Pharma Access have our subject matter experts who boast hands on experience in value engineering of greenfield and brownfield pharmaceutical projects Get in touch with us at sales@pharmaaccess.net or visit us at www.pharmaaccess.net to know more about the services we offer.