Superior Pharmaceutical Testing

Superior Pharmaceutical Testing

ALS is one of the leading providers of pharmaceutical testing in the UK and Ireland.  We offer a comprehensive range of services from our dedicated GMP compliant laboratory located in Ely, Cambridgeshire.

Testing Services

We employ highly experienced and qualified scientists to perform chemical and microbiological testing, covering a wide range of raw materials, API’s, finished products and Pharmaceutical & NHS waters (to CFPP & HTM guidelines). In addition, for storage stability trials we have walk-in stability rooms at standard ICH conditions which are monitored in real-time.
We have strong relationships with our clients; modern, automated instrumentation gives us a diverse and enviable range of testing capabilities so that our clients receive a cost-effective, flexible and professional service.

Pharmaceutical Chemistry testing services include:

  • Finished product and Raw Material Testing
    • For QC batch release
  • Ph Eur (EP), BP, USP, JP Testing
    • Tailored to your requirements

       

  • Water Testing
    • Pharmacopoeial analysis of potable and purified water and WFI
    • Water from steam sterilisers and washer disinfectors (HTM 2030 & 2031)
  • Method Validation (to ICH)

Pharmaceutical Microbiology testing services include:

  • Bioburden & pathogen testing
    • Testing for total viable count (TVC), fungi and specified pathogens to Ph Eur methods
  • Endotoxin Testing
    • Analysis performed on water, raw materials  and finished products.
  • Water Testing
    • TVC by membrane filtration employing various methods: pharmacopoeial, HTM2030 and customer specific.
  • Preservative Efficacy Testing (PET)
    • Pharmaceutical and cosmetic formulations.
  • Disinfectant Efficacy
    • Tailored to customer specific requirements
    • Testing can be performed for manufacturers as well as end users.
    • More information on disinfectant testing

Quality Assured

Ely Pharmaceutical Testing LaboratoryQuality, reliability and consistency are our watchwords.  Clients can have confidence in the integrity of their test results as our own internal, independent quality department undertakes a programme of regular self inspection. We welcome our clients to visit and/or audit us.

  • The laboratory is GMP compliant, MHRA inspected and UKAS accredited to ISO 17025.
  • New equipment is fully validated and documented (full IQ/OQ/PQ).
  • We participate in external proficiency schemes including, EDQM, Pharmassure, LEAP and ILPQ.
  • We are licensed to hold all classes of controlled drugs.

Dedicated Team

Many of our experienced team have extensive pharmaceutical expertise which enables us to provide knowledgeable, proactive support and advice.  Our staff are always more than willing to discuss client specific testing requirements to ensure your needs are met.

Equipment available includes:

  • HPLC (UV, fluorescence, diode-array and refractive index detectors)
  • GC (FID and headspace)
  • FT-IR
  • Total Organic Carbon (TOC) analyser
  • Atomic Absorption Spectrophotomer
  • Dedicated walk-in ICH storage stability rooms monitored in real time
  • Dissolution baths
  • Photostability cabinet
  • UV/VIS Spectrophotometer
  • Viscometers
  • Physical Testing Instruments

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