ALS Life Sciences currently offers Preservative Efficacy Testing, product validation, population assays for Prospore Ampoules Biological Indicators and we are in the process of expanding the testing services offered. The Pharma lab in Clonmel is GMP Compliant and holds approval from the Health Products Regulatory Authority to perform Preservative Efficacy Testing.
To complement the Pharma offering at ALS Clonmel, clients can also avail of the services of a UK based fellow subsidiary, ALS Food & Pharmaceutical, which has over 20 years’ experience of offering a range of high quality analytical testing services across the UK and Ireland through accredited laboratories.
ALS Food & Pharma 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. ALS Food & Pharma have strong relationships with our customers; 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, reliability and consistency are our watchwords. Customers 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 customers to visit and/or audit us.
- ALS Food & Pharma laboratory is GMP compliant, MHRA inspected and UKAS accredited to ISO 17025.
- New equipment is fully validated and documented (full IQ/OQ/PQ).
- ALS Food & Pharma participate in external proficiency schemes including, EDQM, Pharmassure, LEAP and ILPQ.
- ALS Food & Pharma in the UK are licensed to hold all classes of controlled drugs.