Pharma Focus Asia

HOW CAN I USE IBCS IN A PHARMACEUTICAL FACILITY?

Md. Qayamuddin, Md Quamuddin has completed B Pharm and M Pharm from Jamia Hamdard University, New Delhi. Currently, working as an Assistant Professor at School of Pharmaceutical Sciences, MVN University, Palwal, Haryana. He has been teaching for past 7 years and has taught subject like Pharmacology and Human anatomy physiology. He has attended various seminars and conferences and has presented various papers in them. He has several papers in different national and international journals.

During the planning stage of a new pharmaceutical facility, you have a blank sheet of paper; anything is possible. You have time to carefully consider the layout of your facility, time to ensure it has the leanest manufacturing processes, using space in the most efficient way. You also have the opportunity to ensure the new facility meets all GMP standards and will yield efficient OSD manufacturing cycles, which will in turn positively impact the profitability of your business.

One of the biggest considerations during this planning process is whether to build a single or multifloor pharmaceutical facility (where material handling is split across 2 floors separated by a technical area). When space is at a premium and budgets are tight, it is important that the decisions you make are the right ones as they have far reaching implications. Even if budget and space are not constraining factors, being informed now will help you to make better decisions later. In this article, we explore the advantages and disadvantages of single versus multi-floor facilities and what each offers your business.

Single Floor Facilities

When planning a single floor facility, the primary advantage is cost. Typically, a single floor facility is less expensive to build/rent than a multi-floor building. But with less cost there is also less space so you need to plan how to use the space effectively. A particular disadvantage in single floor facilities is in the GMP production area where space is often limited. A solution we frequently recommend is the installation of a pillar lift if there is sufficient ceiling height available. This is a prime example of why you need to consider your processing system choice and the industrial equipment you will be installing, before you commission your building; it’s difficult to increase a ceiling height after construction.

Single floor facilities are also great for improving productivity, especially with the implementation of IBCs where batch transfers can be closed. But for all the advantages there is one primary disadvantage to only having one floor and that is production capacity. While you can achieve multiple batches on a single floor, it’s not as efficient due to the limited amount of space. Scaling up from a single floor facility to meet increased demand can also be costly and quite an upheaval. It is worth considering planning for growth now and building in that extra capacity in readiness for the future.

Multi-Floor Facilities

Although construction or rental costs of a multi-floor facility are often higher than smaller (single floor) facilities, the overall gain in ‘lean’ efficiency can potentially be much greater, especially if you use IBCs. With production split over two-floors, you can use a multi-batch production process, which offers greater potential for scalability and ultimately profitability. The upper floor can be dedicated to powder & granule handling and the lower floor to tablets & capsules. With the benefit of increased space, production areas donot get as crowded as in single floor facilities.

The greatest benefit of a multi-floor pharmaceutical facility is the ability to separate processes by using the divide between the two floors. ‘Clean’ processes can be kept physically separate from ‘unclean’ areas, eliminating possible sources of contamination that might otherwise cause a company to fail regulatory inspections. This is a particular benefit for pharmaceutical manufacturers, where adherence to GMP regulations means that it is essential to isolate potential sources of contamination to generate safe, high quality OSDs.

Having two floors available also means there is no need for mezzanine levels, or pillar lifts required to load IBCs onto equipment. Compared to a singlefloor facility, where everything is made on one level, using the space effectively in a multi-floor facility may mean you coulddesign a smaller building footprint, with smaller yet less crowded rooms that need minimal cleaning, incur fewer health and safety hazards, and are cheaper to buy/rent. Alternatively, the additional space afforded by a multi-floor facility means you can think bigger: achieving larger batch sizes without the extra costs associated with cleaning and storage space.

An example of a multi-floor building layout making the best use of height and space could be…

Upper Floor – Raw material handling and mixing of ingredients

When handling powdered ingredients, a major source of waste is often product lost when transferring raw ingredients from their delivery containers, to the blender and further processes.

Using a Matcon IBC, ingredients can be discharged directly into the receptor, this is also the blending vessel, and thus it eliminates an unnecessary step. What’s more, with closed connections before, during and after IBC discharge, it will ensure a dust-tight transfer, and avoid the risk of contamination and cross-contamination.

With two floors, vertical transfer is a definite possibility, so you can let gravity do the hard work of moving materials between processes. As the IBCs are located on a single floor, it is even possible to remove manual IBC handling and automate these movements using an AGV for example.

Lower Floor – Pressed tablet or capsule packing processes

As they can handle solid granules or particles of any size, including pressed tablets and capsules, Matcon IBCs make handling your intermediate and end-stage products easy and efficient, eliminating the waste often caused by manual processing methods.

Whether you choose to design your pharmaceutical facility on a single or multi-floor layout very much depends on your budget, the space available and your aspirations for business growth. The key to getting it right is planning and designing early before a building is commissioned. Whichever route you take, using an IBC-based production system is the most flexible and efficient way of using the space available while achieving GMP regulations.

Why IBCs?

Flexible, cost-effective, and one of the ‘leanest’ types of materials handling system around, Intermediate Bulk Containers (IBCs) make perfect sense for any manufacturing industry that needs to move powders, granules or tablets between processes.

When it comes to the manufacture of pharmaceutical oral solid dosage (OSD) products, three things are of the utmost concern: quality, safety, and profitability. This is especially true in the manufacture of generic OSD products, where quality and safety demands are stringent, but lower profit margins mean that high volumes must be sold to get a sound return on investment.

Using Intermediate Bulk Containers (IBCs) in a pharmaceutical facility producing generic oral solid dosage (OSD) products is one way to trim production costs without compromising on the products themselves.

Once you have decided that you wish to use an IBC system for your material handling, consideration should be given to the type as not all IBCs are equal in functionality, manageability and performance. Understanding the benefits and limitations of the different types of IBC valve outlet makes for valuable research to give you an informed choice saving you costs in the long term.

A simple butterfly valve IBC might be satisfactory for your current range of products, but as Scientists and R&D develop new therapies and molecules, you may soon find out the limits of a butterfly valve system.

Investing today in a robust, flexible IBC System with proven ability to handle even the most difficult products sets you and your facility up to deal with whatever the future holds. This is where Matcon Cone Valve IBCs can help. In the short term, you can enjoy efficiency benefits over butterfly valve IBCs but in the longer term, you can be confident that your powder handling system will continue to deliver the same performance with more difficult flowing powders or those prone to segregation, without the need to manually intervene or scrap batches.

Who are Matcon?

Established in 1980, Matcon invented the first, unique valve which was game-changing technology. It was designed to control the flow of discharged materials. Matcon went on to create Cone Valve IBCs which have transformed the applications for IBCs compared to traditional methods and are the ultimate ‘lean’ solution for handling powders, granules or tablets.

The ‘lean’ philosophy is all about eliminating waste, because waste – whether that is lost ingredients, spoiled batches, or unnecessarily spent time or effort – all amounts to wasted money. Using an IBC-based production system is cleaner, more efficient and more flexible than other types of traditional manufacturing lines and Matcon strives to support you with a system that brings you the maximum profitability and product quality. Not just selling you a commodity bin, but taking a full look at what your manufacturing needs are and designing a flexible manufacturing system to match those needs, ensuring you are making the right investment.

Can I integrate IBCs into my existing pharmaceutical facility?

Absolutely! IBCs can be seamlessly integrated into almost any size or shape manufacturing space, with significant efficiency savings.

Where can I learn more?

For more information about planning pharmaceutical production lines or the best way to shape the space you currently have, please contact us at www.matconibc.com

--Issue 33--

Author Bio

Md. Qayamuddin

Assistant Professor, School of Pharmaceutical Sciences, MVN University, Palwal, India

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