With a view to continuous improvement, DC Fine Chemicals has built a new QC laboratory in its facility near Barcelona, Spain. Sarah Harding, Editor, spoke to Lenny Loeb, Director at DC Fine Chemicals, about the new facility, maintaining quality in the supply chain, and the company’s future (with Brexit in mind).
DC Fine Chemicals is a supplier of fine chemicals for commercial bioscience applications, offering a broad range of products for customers requiring a reliable partner throughout the development and manufacturing process. Focusing on four business areas — Diagnostics, Life Sciences, Pharma and Process Solutions — the company aims to act as a valuable partner for manufacturers of diagnostic devices, kilo scale synthesis laboratories, pharmaceutical companies and users of reagent chemicals, with a portfolio of more than 2,000 products. Sarah Harding (SH) spoke to Lenny Loeb (LL), Director at DC Fine Chemicals.
SH: Congratulations on your new QC lab! What sort of equipment have you installed in the facility?
LL: Thank you very much, Sarah. We are very proud of our facility in Spain and the lab marks a new milestone in the evolution of our company. Quality is increasingly important to our customers and we believe that our investment in in-house testing is the only way for us to be certain to deliver high quality products to our customers.
For the initial phase of our lab investment we have installed HPLC, IR, UV, melting point, titration and Karl Fischer instrumentation. We do expect further investment in instruments but at this stage we are still uncertain about what we will need next. We list over 2,000 products and we need to decide whether the next investment should be on further chromatography or trace metal detecting instruments. We also have in mind to purchase a portable IR to help with identification that can be used within the warehouse.
We have two full-time staff working in the lab currently and have installed LabWare as our lab management software.
SH: I understand the objective is to test every item DC Fine Chemicals sells. Can you talk us through the practicalities of that process?
LL: Given the wide range of products that we offer, we started the process by categorizing each of our products by the level of testing required. Some technical products will only require identification and assay, while pharmaceutical grade products will require the full list of tests required by the relevant monograph. Accordingly, we have categorised our products as Standard, Superior and Premium.
For new products that we add to our range, for which there is no Pharmacopoeia monograph, our Qualified Person (QP) must research appropriate test methods. Testing of the Pharmacopoeia grade products might be more complex, but documenting the necessary tests is much easier than for the products for which there is no monograph. Otherwise, our QP will rely on their existing knowledge and search the literature to define test methods for each product.
We have had to devise systems for drawing and retaining samples both for testing and storing to allow us to prove our results, if necessary.
Going forward, we will improve our systems for monitoring stock approaching its expiry date and test to extend the shelf life to ensure we can supply products with a minimum unexpired period.
SH: What do you think are the main challenges for maintaining quality in the chemicals supply chain, and how can companies be sure that their suppliers are meeting the right standards?
LL: In the chemical industry, few products are made for only one purpose. Intermediates can be used to synthesize different molecules which, in turn, can be used in widely different industries. Historically, dyes developed for dying fabrics were used as biological stains. We also have experience of biological buffers and UV absorbers being used in printing inks. It is essential to understand what an end user’s definition is of quality.
In relation to generally maintaining quality, personally, I am a believer in working with trustworthy partners. Audits will help to indicate the trustworthiness of partners, but the only way to be certain of quality in the supply chain is through product testing.
SH: Has DC Fine Chemicals embraced ‘intelligent manufacturing’, and how is the movement toward Industry 4.0 impacting the company?
LL: We have future investment plans that would include aspects of Industry 4.0, but the installation of LabWare might be our first step toward that. All our lab instruments are electronically linked to our ERP system so that test results will be maintained and reviewed electronically before they are presented to our Quality Person for review. Our systems are ready for validation and include electronic signature which reduces the risk of human error and saves time in transcribing data from paper to digital format.
Another interface between digital and physical systems is in monitoring our temperature controlled locations. When the temperature in one of these areas is outside of the set range, the Warehouse Manager and Qualified Person are notified electronically. Ideas taken from Industry 4.0 that we plan for future are Datamatrix in the warehouse and connecting the balances in the packing rooms electronically to our ERP system.
SH: With key sites in the UK and Spain, are you optimistic about Brexit? What sort of opportunities do you think Britain’s exit from the EU might offer to the fine and speciality chemicals industry?
LL: I cannot say that we are optimistic about Brexit, but we are resigned to it. Until we know the outcome of Britain’s negotiations with the EU it is difficult to forecast the opportunities that might be available.
The biggest threat would come from the imposition of import duties between Britain and the EU. On the other hand, the fine and speciality chemicals industry could benefit from Britain entering into alternative trade agreements with countries outside the EU.
SH: How is DC Fine Chemicals poised to take advantage of any opportunities that arise?
LL: With our distribution centre in Spain we think that we are well placed to continue our business largely unaffected. We already trade widely outside the EU with about 30% of our business coming from outside of Europe, and we expect this percentage to grow. We are a small and flexible company able to adapt to the political and market changes ahead.
SH: And finally, in general, would you say the future is bright for DC Fine Chemicals?
LL: Absolutely, the future is bright for DC Fine Chemicals. We started the business in late 2007 and, in our infancy, weathered the “crisis” and grew sales every year. Concentrating on customer service and quality has worked well for us in the past and, we believe, will continue to be successful.