1. Can you explain how Matcon IBC solutions are used in API and Solid Dosage industries?
In both of these industries, Matcon IBC Solutions are utilized to move materials between processes in an efficient, flexible and contained manner. Closed connections protect the product from contamination and cross contamination as well as safeguarding the operators from hazardous materials.
Specifically in the API industry, the Matcon Cone Valve has the unique ability to effectively and reliably handle solvent-rich wet cake material. This enables the Matcon IBC Solution to be used for transfer of materials between the centrifuges and dryers – something that other IBCs just can’t do. It is also normal for our customers in this industry to use IBCs for sieving, milling and pack-off to drums. For these processes, the Matcon Cone Valve Technology gives the ability to directly control and shut-off powder flow in either volumetric or gravimetric mode.
For Solid Dosage applications, Matcon IBC Solutions are applied from initial dispensing of powders through to handling of granules and tablet handling. When handling powders, the Matcon IBC Cone Valve provides complete and reliable discharge of material to wet granulation systems, roller compactors and tablet compression machines. Granules and powders can be tumble blended directly within the IBCs using a Matcon IBC Blender. In addition, Matcon has a complete tablet handling solution which enables tablets to be gently handled in complete coating batches of as much as 750Kg.
2. Matcon is becoming bigger day by day. So, what are the biggest challenges for Matcon in today’s competitive marketplace?
The focus of the pharmaceutical industry and new investment in the pharma industry move around the globe continually and the challenge for a systems supplier such as Matcon is to always stay in touch with the changing market requirements and respond to this change of location. An example of this is that Matcon has invested in creating a team who are based in Mumbai to support and serve our customers in the Indian market.
3. What are the key regulatory challenges during the development and manufacturing of Oral Solid Dosage?
The validation of blending quality is one of many key regulatory challenges. Traditionally, validation at this stage of the process is carried out by manually taking samples immediately following the blending process, however this has a number of disadvantages:
• There is a cost attached to this traditional method of sampling and sample analysis.
• Sampling in this way introduces delays in the process and creates additional work-in-progress.
• Traditional sampling methods result in a pass/fail result and give very little process understanding.
• There is a risk of segregation occurring between blending and feed to compression, capsule filling etc. and therefore sampling directly after blending does not guarantee a quality bend later in the process.
To overcome these issues, Matcon is working with NIR technology which provides monitoring and validation of the blend quality without the need to take manual samples. This technology also provides real time data that enables a far better understanding of the process performance.
In addition, by using IBCs, the blended material can be directly moved above the compression or capsule filling machine. Matcon IBC Cone Valve technology ensures that the quality of blend is maintained right up to the inlet of the machine and, again, NIR can be used here to validate that blend homogeneity is being maintained.
4. Going a bit further, how will oral solid dosage manufacturing process accelerate pharmaceutical development over the next three to five years in your opinion?
We are seeing a growing trend in the industry of generic manufacturers who are looking to increase the amount of variability (number of drugs and SKU’s) whilst maintaining high levels of productivity and quality.
Flexibility and the capability to operate at different scales are therefore important considerations for our customers who are requiring agile production processes to respond to these pharmaceutical developments.
Specifically in response to this, Matcon offers a wide range of standard IBC volumes, up to 3500L, and solutions to enable different sized IBCs to be used interchangeably throughout the production process (for example, it is possible to blend blended 200L IBCs and 3500L IBCs on the same Matcon Blender).
5. Matcon has offices in USA, UK, Europe, and South Africa. Is there any chance of establishing Matcon’s subsidiary in India?
With India being identified as a key region for future growth a few years ago, Matcon opened a new enterprise in Mumbai in April 2015. Our Sales and Business Development team come with a wealth of knowledge, having been involved in the pharmaceutical industry for over 15 years. We are further supporting the region by exhibiting at P-Mec India between 21st and 23rd November and in Bangladesh at Asia Pharma Expo in February 2017.
6. Matcon’s solutions for Oral Solid Dosage are also applicable to manufacturers of Nutraceutical and Veterinary products. What are the advantages of using these solutions?
Many of the advantages are common across all of these industries, including:
• The Matcon IBC System has the ability to effectively handle a wide range of materials due to the Cone Valve technology, ensuring full discharge of materials without segregation of the blend.
• High hygiene levels and validated cleaning systems.
• Proven systems operating in GMP compliant and FDA-approved facilities.
• Containment solutions, avoiding risk of cross-contamination and risk to operators.
• High production flexibility and productivity.
7. In addition to ‘Parallel Processing’, ‘Lean’, what are some other technological innovations that will help companies improve processes, development costs, and timelines?
As we mentioned in Q3, the combination of NIR technology and IBC Blending offers new opportunities to our customers to validate blends without sampling.
Our development of a gentle tablet handling system now enables customers to handle tablets safely and efficiently in large quantities. This system reduces operator handling time, improves the OEE of the coaters and other processes, and gives improved inventory control and traceability of tablet batches.
8. What role does LEAN materials handling play throughout manufacturing process?
Lean materials handling is central to Matcon’s material handling philosophy.
For powders, granules and tablets, we maximize the batch size that is contained in a single IBC in line with the capacity of the downstream processes. By operating in this way, we strive to minimize the number of make/break connections for IBC filling and emptying by significantly reducing the number of containers required throughout the production process (e.g. one IBC replaces many drums).
9. Will Matcon IBC solutions have a significant impact on the installations?
Matcon IBC solutions can significantly improve the product quality, productivity and equipment effectiveness of the whole production process.
In addition, our customers benefit from contained and dust tight materials handling and the Matcon IBC solution is a central part of a lean and agile pharmaceutical facility design.
We also add value by helping at the Building Design stage. We can help to formulate the right batch sizes to optimise materials handling and reduce manual operations ensuring you have a smooth running, efficient production system for maximum productivity.
10. Where would Matcon Systems benefit the most from new technology or innovation?
Our R&D team keeps up to date with new technology and innovation, and we are continually looking for ways to improve designs and add value to the solutions that Matcon offers.
Tracking and traceability are important requirements of any production facility and Matcon has experience of providing IBC Systems with bar code and RFID identification. This is a growing demand within the industry and as technology develops in this area then the costs will reduce and availability increase, making this type of traceability an integral part of every production system.
11. What tools and techniques does your lab use to ensure installation runs smoothly?
Within our test facilities worldwide, we have the ability to carry out evaluation and categorization of materials e.g. we assess flowability of powders, bulk density of materials, angle of repose, particle size distribution, moisture content etc.
In addition to the laboratory analysis, Matcon is a firm believer of full scale testing and we have facilities in a number of our global locations for our customer’s to perform tests with their own materials or a suitable placebo product. Typically these tests would incorporate blending, powder/tablet discharge and equipment cleaning.