Good Practices – PharmaAccess Blog

February 10, 2025February 10, 2025

Sustainable Facility Design: 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:

Imperfect burner mixing capabilities – Burners may not mix air and fuel evenly.
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:

Insufficient Air

Leads to incomplete fuel combustion, causing:

Reduced heat output
Increased carbon monoxide (CO) emissions
Potential regulatory non-compliance

Excessive Air

Leads to efficiency losses through:

Heat loss through flue gas
Reduced combustion efficiency
Unnecessary energy waste

Optimization Strategies for Boiler Efficiency

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)

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.

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

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.

August 31, 2021December 4, 2024

Good Manufacturing Practices: Sterile & Aspectic Processing

Whenever we talk about a greenfield pharma facility, GMP and its compliance has always 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 and this article will throw some light on how some small to mid sized manufacturing facilities can achieve its 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 preserves the safety of the end-user: the patient, it also ensures
that the risk of contaminating the product is reduced or detected and controlled quickly, thereby

Maximizing operational efficiency
Eliminating wastes
Improving organization’s bottom line

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

Many alternative automated methods can replace traditional methods that can 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.

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 particular 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, which creates higher throughput in the lab’s general operation. It also reduces stress and anxiety on the staff by reducing the chances of error, the need for retests, and the potential burden of performing investigations for root cause. These alone can greatly improve the overall value, utility, and employee satisfaction in an organization.

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 trust the ease and comfort of traditional methods. However, they fail to realize that as a startup, they have the perfect opportunity to innovate and use modern methods in the beginning, rather than try to overcome inertia and reliance on these methods later. Investing the time to gain the knowledge and experience of using the best available methods early will set up startups

for success for years down the road. Using rapid, alternative methods not only ensures GMP compliance right out of the gate, but 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 that include: no cleaning validation; easy product changeover, particularly for multi-product facilities; and no cross contamination. Additionally, working with a reliable and trusted partner like Pharma Access with knowledge of GMP regulations means that revalidated components are easily incorporated into processes and they can also provide effective support and verification of their supply chain.

We at Pharma Access have our subject matter experts who boast hands on experience in GMP compliance documentation 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.

August 30, 2021December 3, 2024

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.