Bespoke testing is how Edwards' Analytical all started. We understand that every situation is unique and tailor our approach according to your needs. We value open communication with all of our clients and welcome face to face discussions about your project and your needs.

  • Investigative
  • Consultancy
  • Safety assessment
  • Product pack interactions
  • Product failure or malfunction

 As well as our bespoke investigational testing we offer routine testing services:

  • In-house analytical methods and SOP’s
  • Client supplied proprietary methods
  • Pharmacopeia – USP/EP/JP/BP
  • International testing standards (ISO/ASTM/DIN)
  • Country specific regulations e.g. food contact
  • REACH directive

Edwards' Analytical ensure that the range of services offered is thorough and capable to meet your expectations, we are pleased to offer the following analysis:

  • Analysis of water including water for injection to (USP, EP, JP, HTM2010)
  • Endotoxin analysis  (turbidometric, chromogenic and gel clot)
  • Analysis of raw materials to (USP, EP, JP, HTM2010)
  • Disinfection efficacy testing
  • Bioburden of packaging materials
  • Preservative testing
  • Identification of microorganism
  • Environmental monitoring
  • Sterilization and troubleshooting consultancy
  • Identification of yeast and moulds

Our microbiology contract testing services range from the identification of microorganisms and water system validation through to preservative efficacy testing of raw materials. Backed up by proven methodology and industrial experience, we can undertake a wide range of studies to suit your needs.

With an increased trend amongst regulators toward the independent analysis of raw materials, many manufacturers are using our flexible approach to meet with the ever increasing demands placed upon them. The scientists within our microbiology laboratory are all experienced in working within the pharmaceutical and medical device industries. They're highly skilled in generating protocols and methodologies to suit the needs of each individual project, from the first concept through to the finished product.

Product packaging is highly ubiquitous.

It is a primary component to many manufactured products, whether these are FMCG, food, pharmaceutical, chemical, electrical or other industrial products. Packaging components are assembled from a variety of materials including; plastics and rubbers, glass, ceramics, paper, carton board and metals.

There are also variations of each type, for example, low & high density polythene, nylons, tin, aluminium and stainless steel cans. They are also highly decorated, for example with various inks and adhesive labels. A trip to a supermarket will demonstrate the very wide range of materials used for different products.

All packaging, regardless of composition and purpose, is subject to stringent regulations, such as;

  • Packaging must adhere to the requirements of the Packaging and Packaging Waste Directive (Directive 94/62/EC) which aims to harmonise national measures in order to reduce the impact of packaging and packaging waste on the environment.
  • Packaging used for toys must conform to the Toys Regulations.
  • Packaging for cosmetic products must conform to the Cosmetics Regulations.
  • Food packaging as well as food processing and storage equipment must conform to the Food Contact Regulations.
  • Pharmaceutical packaging must conform to Pharmacopoeia specifications including; the European Pharmacopoeia (EP or Ph. Eur.), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP) and the United States Pharmacopoeia (USP) depending on the country to which the packaged product is being marketed.
  • A number of testing standards can apply to packaging including ASTM, ETSI, ISO, ISTA and TELCORDIA.

Packaging testing is required to demonstrate adherence to these regulations.

Packaging components can be tested in a variety of different ways and commonly testing is required to demonstrate packaging durability, packaging performance, packaging quality and packaging-product interactions.

Physical Testing of Packaging

  • Packaging Stress Tests - Subjecting packaging to stresses and forces that would be experienced in its normal use will demonstrate durability and identify whether a particular packaging material is ‘fit for purpose’.
  • Damage Testing- Involves the reproduction of damage effects seen in the field and during transportation.
  • Dropping – Packaging is dropped to show durability under normal usage conditions
  • Crushing – Packaging is compressed to show resistance levels and the ability to protect contents.
  • Vibration Testing – Various forms of transportation relation vibration can be replicated to identify packaging performance under these conditions.
  • Water – Water is sprayed onto the packaging and stored at a consistent temperature to identify if contents may be damaged through leaking.
  • Dimensional Testing – To conform size and shape of the packaging compared with tool and CAD drawings.

Chemical Testing of Packaging

  • Contaminant Analysis– If contamination of a product by its packaging is suspected, contaminants can be confirmed and identified.
  • Chemical and Metal Trace Analysis – Required for pharmaceutical packaging.
  • Extractables and Leachables Testing – For example, required in the food industry. Packaging is tested for potentially harmful chemicals, such as polymer catalyst residues, that could leach into food products being housed.

Equipment required to test packaging includes; Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Gas and Liquid Chromatography-Mass Spectrometry (GC-MS/LC-MS), Fourier Transform Infra-red Spectroscopy (FT-IR) and Nuclear Magnetic Resonance (NMR) Spectroscopy, as well as mechanical jaws, vibration benches and cranes.

Universal Testing Machine

Universal testing machine, also known as a universal tester, materials testing machine or materials test frame, is used to test the tensile stress and compressive strength of materials. It is named after the fact that it can perform many standard tensile and compression tests on materials, components, and structures.

Typical tests that we undertake include tensile, compression and flexural modulus. Example applications include extension modulus,  coefficient of friction, seal strength, activation force and surface tension.

Metrology

Our physical testing laboratory has an impressive suit of dimensional and microscopy instruments for determining macro and micro objects, including: 

  • Dimensional using baty shadow graph
  • Optical And scanning electron microscopy for nano particle analysis
  • Particle Size Distribution (Sieve and Laser Diffraction) of powders and matrices, including aerosols and vapours.
  • Hardness shaw A and D for rubber and foams.

Barrier Migration

Here at Edwards' Analytical we offer a variety of testing standards including ASTM to  evaluate the barrier properties of packaging and materials.

Water and oxygen

Using a suit of MOCON apparatus, we can test carton, filmic materials and also containers for their barrier properties and seal integrity over time.

Furthermore, using conventional dish and pack testing, we can conduct frequent water vapour permeation testing particularly to the USP monograph <671> which monitors weight gain as mg/litre/day.

Organic compounds

Using sealed inspection and conditioning chambers, Edwards' Analytical can examine to very high levels of detection ingress / egress of complex organic compounds such as perfumes through packaging presented as headspace analysis using our GC-mass spectrometer.

Malodour testing

Edwards' Analytical offers a service in partnership with an associate company of ours for examining malodour challenge testing often conducted as part of stability trials.

Raw materials are the basic substances from which goods, products or other intermediate materials are made or produced.

Raw materials are found in a vast array of industries including chemical and pharmaceutical, industrial, food and drink, construction, medical and electrical.

Examples of common raw materials used in industry include crude oil, wood, coal, seawater, various chemicals and raw latex.

Raw materials can be tested using a wide variety of techniques and equipment such as.

  • High Performance Liquid Chromatography (HPLC)
  • Gas Chromatography
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Atomic Absorption (AA)
  • Graphite Furnace Atomic Absorption (GFAA)
  • Fourier Transmittance Infra Red (FTIR)
  • Nuclear Magnetic Resonance (NMR)

Edwards' Analytical has a comprehensive range of specialist equipment and expert staff capable of providing high quality raw materials testing and analysis services. We are able to provide a wide range of raw material testing services to meet all current standards and regulatory requirements, including:

  • Verification testing
  • Specification testing
  • Raw material monograph analysis to pharmacopoeia guidelines
  • Impurities analysis
  • Method development and validation

For further information regarding raw materials regulations and the laboratory services we can offer, please contact us.

Qualification of manufacturing and laboratory equipment

We have experienced and dedicated scientists who can devise and prepare detailed qualification plans and written qualification protocols and reports.

The consultants will also perform the invigilation of the qualification protocols in addition to providing the analytical testing capabilities.

Validation of manufacturing processes, cleaning procedures and analytical procedures

Edwards' Analytical can perform the Manufacturing and Analytical Validation activities as per the Qualification activities withthe same amount of experience and dedication.

Validation of utilities

Edwards' Analytical has experienced chemists and microbiologists in pharmaceutical water systems who can provide the expertise to devise regulatory acceptable validation programmes.

As well as providing the analytical testing facilities for the volumes of water samples, advice will be provided in the investigation of any deviations and atypical results achieved during and beyond the validation periods.

 

Auditing of suppliers of systems, and audit preparation awareness

As part of a pharmaceutical quality management system, the auditing of raw materials and Active Pharmaceutical Ingredient (API) suppliers is a critical parameter, to which we can provide assistance. 

All of these activities will be supplied with fully compliant cGMP and auditable documentation and also on-going support for the services provided.

 

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