PharmaMail 1 - Spring Newsletter - ALS UK Pharmaceutical

Monday 5th February 2024

Investment and another expansion at ALS Ely

In line with our ongoing dedication to continuous enhancement, the Ely laboratory is making substantial investments in its team and analytical capabilities. Recently, we invested £100K in two new automated dissolution baths with fraction collectors to meet the growing demand for dissolution testing and profiling of prolonged release dosage forms. These additions complement the existing six baths already in use.

Furthermore, Ely has acquired an additional Dionex™ Integrion™ HPIC™ System with a reagent-free controller, enhancing the system's efficiency with automated eluent generation (EG) for improved reproducibility. The increased reliance on modern technologies by the USP for identifying and quantifying anions and cations has prompted the need for expanded testing capacity.

Excitingly, following the successful £2.1M refurbishment and expansion in 2016, the ALS Ely site is planning another expansion. The Management Team is actively working on expansion initiatives to support the continuous growth of Ely's analytical service portfolio. With the addition of sterility testing within isolators, ALS aims to offer a comprehensive laboratory solution for both sterile and non-sterile importers and manufacturers in the UK, addressing the market's testing needs and providing contingency measures. Stay tuned for more updates!

Burkholderia cepacia complex (BCC)

The Burkholderia cepacia complex (BCC) presents a contamination risk that has been a significant topic of discussion and a well-known concern within the non-sterile and personal care manufacturing sectors for many years. One of the primary pathways for its persistence in water-based non-sterile products is through deficient water systems. In December 2019, the USP <60>, Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex, was implemented. This chapter outlines a microbiological testing protocol to detect the presence, or ideally the absence, of Burkholderia in various sample matrices. In April 2023, the US-FDA issued additional guidance for manufacturers, leading to extensive risk assessments and reassessments of purified water systems. In anticipation of the growing need to enhance contamination control measures, the Ely site has expanded its non-sterile microbial testing services to include Burkholderia cepacia Complex testing on water and product samples. It is essential to validate the test procedure in the presence of the product, preferably before the routine quality control testing begins, mirroring broader non-sterile microbial testing practices. ALS Ely stands out as one of the few US-FDA audited non-sterile microbiological contract laboratories in the UK that supports BCC testing.

‘Difficult’ Raw Material Testing – We love it!

ALS is actively working towards standardizing its laboratories worldwide. As part of its global strategy, a key aspect involves establishing a 'hub and spoke' laboratory network to centralize expertise across different locations. Recently, ALS Odense in Denmark, previously known as DB Labs A/S, became part of the ALS group in May 2022. Their testing services cover the same areas as Ely, with a specific emphasis on raw material testing to meet the requirements of the local pharmaceutical industry in the Nordic Region. As an approved subcontractor of ALS Ely, ALS Odense now offers a wider range of testing services that are inherently more complex than standard tests like Sodium Chloride.

Notable examples include:

  • Talc & Silica Testing – Odense has a dedicated laboratory area for the handling and use of Hydrofluoric Acid
  • Determination of Nitrogen and Protein Content by Kjeldahl (Ph. Eur. method 2.5.9) - Kjeldahl instrument is a FOSS 2100 Kjeltec System distillation unit.
  • EP compliant Mycotoxins testing using HPLC-FLD (Determination of Aflatoxin B1 in Herbal Drugs, Ph. Eur. method 2.8.18 & Determination of Ochratoxin A in Herbal Drugs, Ph. Eur. method 2.8.22)
  • Gel strength (bloom value) of gelatin according to the European and U.S. Pharmacopoeia.
  • EP and USP Herbal Drug Assays using HPLC’s with Evaporative light-scattering detection (ELSD)
  • Meglumine, Dextranomer & Dalteparin sodium: EP Specific element determinations by Inductively coupled plasma-atomic emission spectrometry (ICP-AES / ICP-OES) (Ph. Eur. 2.2.57)