ALS Food & Pharmaceutical

At ALS we have established an unrivaled testing service, incorporating the analysis of raw materials, intermediates and finished products.

With a comprehensive range of tests, qualified analytical equipment and experienced and skilled staff, clients can have confidence in the integrity and quality of test results. Our laboratories are GMP compliant and accredited to ISO 17025. Here is a taste of what we offer:

Chemical Techniques and Equipment

• HPLC (UV, diode-array, MS, RI and Fluorescence detectors)
  
• GC (FID, ECD, TCD, MS, MSMS and headspace)
  
• High Performance TLC
  
• ICP (OES, MS)
  
• Ion Chromatography
  
• Atomic Absorption Spectrophotometer
  
• Dissolution Testing
  
• FTIR
  
• Karl Fischer Titrator
  
• Auto-titrator
  
• Total Organic Carbon Analyser
  
• UV/VIS spectrophotometer
  
• Refractive Index
  

Physical Testing

• Hardness
  
• Disintegration
  
• Dimensions
  
• Appearance / Colour / Odour
  
• Viscosity
  
• Melting Point
  
• Friability
  
• Uniformity of Weight
  
• Specific Gravity

At ALS we have a proven track record of delivering method development projects across a range of analytical methodologies.

We specialise in method development for HPLC, GC and ICP analysis.

• Disinfectant Efficacy Testing
  
• Suspension testing, BSEN 1276, 1650, 13704 (Phase 2,step 1) for bacterial, fungicidal and sporicidal assessments
  
• Surface testing BSEN 13697 (Phase 2, step 2) for bacterial and fungicidal assessments
  
• Tailored to client specific requirements - to conclusively demonstrate that their disinfectants are effective under the conditions in which they are used.
  
• Testing can be performed for manufacturers as well as end users

ALS’s extensive suite of methodologies gives you confidence that we can provide the solutions you require.
Through our network of GMP and ISO accredited laboratories, highly experienced staff and extensive range of microbiological tests, ALS provides customers with cost-effective quality assurance. We have a range of test methods available to meet your requirements.

Microbiological Quality Testing

• Microbial Limit Testing
  
• Total Viable Count (TVC)
  
• Total Yeast, Mould & Fungi Count
  
• Microbial Identification
  

Absence of Specific Pathogens

• Staphylococcus aureus
  
• Pseudomonas
  
• Escherichia coli and Coliforms
  
• Salmonella
  
• Candida albicans
  
• Bile Tolerant Gram Negative Bacteria
  
• Clostridia
  

Water

Analysis by membrane filtration for:

• Total Aerobic Count
  
• Escherichia.coli
  
• Pseudomonas aeruginosa
  
• Coliforms
  

Sterility Testing

• Microbial Identification by DNA sequencing
  

Environmental

• Settle Plates Total Bacteria, Yeast and Mould
  
• Air Plates Total Bacteria, Yeast and Mould
  
• Contact plate analysis
  
• Swab and sponge analysis
  
• Gowning contact plates
  
• Finger dabs
  
• Sampling
  

Other Microbiological Services

• Preservative Efficacy Testing (PET)
  
• Pharmaceutical formulations oral, topical, injectable
  
• Cosmetic formulations
  
• Bacterial Endotoxin Test (LAL) - Gel Clot and Turbidimetric methods

ALS is a one stop shop for your stability trial design, storage, analysis and data trending.

Being an essential component of pharmaceutical development, stability studies allow the evaluation of product stability under the influence of various environmental conditions. These include temperature, humidity and light, simulating different climatic zones from around the world. The data from such studies can be used by the client to establish recommended storage conditions, retest periods and shelf life.

ALS offer ICH stability storage and testing programmes for a wide range of APIs, pharmaceuticals, biopharmaceuticals, medical devices, chemicals and cosmetics, whether required for initial product registration and/or Product Quality Review (PQR).

Our purpose-built walk-in stability rooms are fully validated to meet GMP regulations and can be utilised for both long term and short-term shelf life studies. All rooms are monitored in real time and we operate emergency back-up facilities on site, allowing business continuity and complete peace of mind for our clients.

We can provide a solution tailored to your requirements - storage only or full storage plus testing. Samples can be stored and scheduled for testing or shipped to your chosen location at each time point or as required.

Security

• All chambers are kept locked, with restricted access
  
• Audible and visual alarms for temperature and humidity (above and below set conditions)
  
• Data loggers have email and auto dial alert functionality
  
• UPS on data logger ensuring continuous monitoring and alarm call outs
  

Definition of Zones

• Zone I: Temperate climate
  
• Zone II: Subtropical and Mediterranean climate
  
• Zone III: Hot and dry climate
  
• Zone IVa: Hot and humid climate
  
• Zone IVb: Hot and very humid climate
  

Stability Storage Conditions Available

• 5ºC
  
  • Long term conditions for cold stored products or retained/control samples
    
• 25ºC/60%RH
  
  • Long term conditions for climatic zones I and II
    
• 30ºC/65%RH
  
  • Intermediate and long term conditions for climatic zones I, II,III and IVa
    
• 30ºC/75%RH
  
  • Long term conditions for climatic zone IVb
    
• 40ºC/75%RH
  
  • Accelerated conditions for climatic zones I, II, III and IV
    

ALS also offer photostability testing in accordance with ICHQ1B (option 2).

Method Validation:
We are highly experienced in chemical and microbiological method validations across many techniques and product types.

We can assist throughout the entire process including project planning, protocol preparation, and analytical testing to final project report.

Key test method areas in which we have expertise include:

• Dissolution profile studies
  
• Compendial methodologies bespoke to your product formulation
  
• Stability indicating test methods to comply with ICH

Ensuring food is safe from microbiological contamination is a priority and a legislative requirement at all stages of the food chain.
Through our network of accredited laboratories, highly experienced staff and extensive range of microbiological tests, ALS provides customers with cost-effective quality assurance from ‘farm to fork’.

Microbiological tests include:

Pathogens

• Salmonella spp
  
• Listeria spp
  
• E.coli 0157
  
• Campylobacter spp
  
• Shigella spp
  
• Vibrio spp
  

Typical enumerations

• Bacillus cereus
  
• Cl. perfringens
  
• Coliforms
  
• E.coli
  
• Enterobacteriaceae
  
• Lactic Acid Bacteria
  
• Pseudomonas aeruginosa
  
• Staphylococcus aureus
  
• Total Viable Count (TVC)
  
• Yeast and Moulds
  

In addition to routine microbiological analysis of food samples, we also offer the following services:

• Shelf-life evaluation with standard storage conditions (refrigerated or ambient) or bespoke trials to mimic consumer use with package opening and storage temperature changes as required.
  
• Environmental monitoring – using swab samples, contact plates or settle plates.
  
• Hand swabs – monitoring for Staphylococcus aureus and E.coli
  
• Water testing
  

We have a range of test methods available to meet your requirements (traditional or rapid) and to comply with specific retailer standards.

Formulation & Manufacturing Services

Water Quality Monitoring Services

Environmental & Geological Sciences Services

Manufacturing Services

Agricultural Toxicity Tests Services

Agricultural Testing Services

Agriscience Services