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.

 

 

Edwards’ Analytical

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General Conditions Edwards’ Analytical Limited.

These General Conditions apply to and are an integral part of all services, assignments and consultations to be carried out by Edwards’ Analytical Limited to be called Edwards’ Analytical Limited”. The applicability of the General Conditions of the Client will not be accepted by Edwards’ Analytical Limited and are hereby expressly rejected unless otherwise agreed as part of the quotation process.

 1.         Article 1 – Agreement

1.1.     These General Conditions apply to all offers, provision of professional services and agreements (hereinafter: ‘the Agreement’) between Edwards’ Analytical Limited  and a third party (hereinafter: ‘Client’) with regard to the carrying out of research, tests and/or the provision of consultations, and the performance of works, (Hereinafter ‘the Assignment’) by Edwards’ Analytical Limited  for the Client.

1.2.     Any offers by Edwards’ Analytical Limited are without obligation. An Agreement is only binding for Edwards’ Analytical Limited after a written order confirmation by Edwards’ Analytical Limited.

  1. 2.         Article 2 – General Conditions

2.1.     It is explicitly agreed, that these General Conditions between Edwards’ Analytical Limited and the Client exclude the applicability of any terms and conditions, of any kind, of the Client, even if precedence is claimed in those terms and conditions.

  1. 3.         Article 3 – Samples

3.1.     The Client bears the responsibility for the selection, representativeness, coding brand and product names, and the provision to Edwards’ Analytical Limited of samples, materials, raw materials, products, semi-finished products and end products to be tested / researched. The Client is obliged to notify Edwards’ Analytical Limited of any hazardous properties of any samples, materials, raw materials, products, semi-finished products and end products in a clear manner in writing and to mark the samples, materials, raw materials, products, semi-finished products and end products as hazardous.

3.2.     Unless agreed otherwise, the Client will collect any samples, materials, raw materials, products, semi-finished products and end products that have been provided to Edwards’ Analytical Limited  in relation to the execution of the Agreement, or, if such is the case, the remains of such samples, materials, raw materials, products, semi-finished products and end products, immediately after performance of the Works and will provide Edwards’ Analytical Limited  with a proof of receipt.

If the Client does not collect the (remains of) any samples, materials, raw materials, products, semi-finished products and end products, or does not do so in time, Edwards’ Analytical Limited has the right to store, destroy, or otherwise relieve itself of these at the expense and risk of the Client. Transport and storage of the samples, materials, raw materials, products, semi-finished products and end products and remains thereof will take place at the expense and risk of the Client.

  1. 4.         Article 4 – Use of the Research Results

4.1.     All reports and pertinent data issued will be sent electronically as PDF. Should the Client require original signed hard copy, this will be requested directly by the client in the project request, and provided at additional cost as specified in the quotation.

4.2.     The Client is not permitted to use any reports published by Edwards’ Analytical Limited with regard to the Works for publication (in full or in part), to provide to third parties for viewing, or in claims by or against the Client without prior written permission. The Client is also not permitted to use the name of Edwards’ Analytical Limited in relation to the works.

4.3.     If Edwards’ Analytical Limited provides this permission, it comes with the condition, unless agreed otherwise in writing, that the Client may not use the results of the works in such a way that in any way detracts from or contradicts the correctness of those results.

4.4.     The Client will receive non-transferable rights of use, free of charge, with regard to the documents and published results of the Works, in the understanding that all industrial and intellectual property rights in relation to the Works and the results thereof are the sole property of Edwards’ Analytical Limited  and that Edwards’ Analytical Limited  has the exclusive right to submit patent applications with regard to these.

  1. 5.         Article 5 – Price and Payment

5.1.     The amount payable by the Client for the Works will be determined in the offer provided by Edwards’ Analytical Limited. If, however, an amount is stated in the order confirmation that deviates from the amount in the offer, the amount in the order confirmation will apply. The invoice will be specified at the request of the Client. If no fixed price was agreed, then it is agreed between Edwards’ Analytical Limited  and the Client that the amount payable will be determined on the basis of cost, unless stated otherwise in the offer (or order confirmation), the amount payable is excluding all costs, taxes (such as VAT), variable costs, levies, costs in relation to the Works regarding the answering of legal complaints and actions by third parties (including oppositions and lawsuits) and all external costs, which are at the expense of the Client.

The Client will make payments within 30 days of the date of the invoice. Edwards’ Analytical Limited reserves the right to add interest at 8% over the base rate for late payments. Edwards’ Analytical Limited reserves the right to add debt recovery costs in force at the time of the debt.

5.2.     If parties agree that more work will be carried out than determined in the Agreement, this extra work will be carried out under the same conditions as originally agreed, unless parties have agreed otherwise explicitly and in writing.

5.3.     Edwards’ Analytical Limited will hold the property rights on all goods that Edwards’ Analytical Limited provides to the Client in relation to the Works, such until the moment at which the amount(s) owed to Edwards’ Analytical Limited by the Client are paid in full.

  1. 6.         Article 6 – Outsourcing

6.1.     The consent of the Client is required for the recruitment of third parties for the execution of the assignment, if and insofar as any foreseeable risk with regard to confidentiality arises as a result of this. The Liability arrangement in Article 7 is applicable to Works carried out by third parties and also applies mutatis mutandis with respect to these third parties.

  1. 7.         Article 7 – Liability and Guarantee

7.1.     Edwards’ Analytical Limited will carry out the Works to the best of its ability, however, without guaranteeing that any results desired by the Client will be achieved.

7.2.     The Client is obliged to provide all relevant information that can be of use to the execution of the assignment and is known to them to Edwards’ Analytical Limited. The following are considered relevant information: previous similar cases, important events, previously submitted applications and publications, which apply to the same area. The Client will protect Edwards’ Analytical Limited from any liability against third parties for damage that is the result of the provision of incorrect information to Edwards’ Analytical Limited. When Edwards’ Analytical Limited provides documents to the Client for approval and comments, it is the task of the Client to check the document for inaccuracies and mistakes, also with respect to the technicalities.

7.3.     Edwards’ Analytical Limited will notify the Client of any changes to the status of the intellectual property rights. The Client will provide the necessary information to Edwards’ Analytical Limited in time, to enable Edwards’ Analytical Limited to respond to ‘official actions’. If the required information is not provided in full, or is not provided in time, Edwards’ Analytical Limited will not be liable for the consequences thereof.

7.4.     Edwards’ Analytical Limited is only liable for imputable damage suffered by the Client as result of non- (timely) compliance by Edwards’ Analytical Limited or by employees or third parties hired by Edwards’ Analytical Limited.

The Maximum amount for which Edwards’ Analytical Limited will be liable is the amount payable by the Client to Edwards’ Analytical Limited in accordance with the Works carried out under the Agreement. These limitations of liability do not apply in cases of intent o gross negligence. If the execution of the Agreement takes longer than one year, Edwards’ Analytical Limited ’s liability will be limited to the (average) amount that the Client owed Edwards’ Analytical Limited in the previous year (years). Under no circumstances will Edwards’ Analytical Limited be liable for indirect of consequential loss.

7.5.     The Client will indemnify Edwards’ Analytical Limited and any persons hired by Edwards’ Analytical Limited for the execution of the Agreement against all third-party claims in respect of damage suffered by these third parties, in relation to the application or use of results of the Works by the Client or by any other part who has received these results either directly or indirectly from the Client.

7.6.     Edwards’ Analytical Limited is not liable for damage that is a result of the fact that the results of the Works are not suitable for carrying out legal procedures or if an infringement of the rights of third parties occurs through the application of the results of the Works.

7.7.     Claims from the Client against Edwards’ Analytical Limited , which arise from or are otherwise related to the Agreement or the (carrying out of) Works by Edwards’ Analytical Limited , or by persons or third parties hired by Edwards’ Analytical Limited  for the carrying out of Works, will be entirely void if such claims have not been notified to Edwards’ Analytical Limited  explicitly and in writing within one year of the date of the final invoice.

  1. 8.         Article 8 – Premature Termination

8.1.     If the Client does not comply, or does not comply in time or correctly with an or all essential obligations arising from the Agreement, and also in case of (filing for) bankruptcy, liquidation or dissolution of the company, or requests or the provision of a moratorium on payments, Edwards’ Analytical Limited  has the right to prematurely terminate or suspend the Agreement in full or in part, without the need for a notice of default or mitigation and without the liability to pay damages, without prejudice to any other rights of Edwards’ Analytical Limited . As soon as one of the above conditions applies, all claims that Edwards’ Analytical Limited has on the Client become payable on demand.

  1. 9.         Article 9 – Confidentiality

9.1.     Edwards’ Analytical Limited obliges itself to keep any results confidential, insofar as the results of the Works are related to the company or the business practice of the Client, and not to bring these to the attention of third parties other than in case of legal obligation or a court order. Edwards’ Analytical Limited will also keep other results of the Works confidential for a period of two years from the date of the final invoice, without prejudice to the right of Edwards’ Analytical Limited to submit patent applications based on the stipulations in Article 4 section 2.

9.2.     The Client guarantees confidentiality of all information that comes to be known to them, which relates to the company or the business practice of Edwards’ Analytical Limited.

  1. 10.      Article 10 – Health and Safety

10.1.     If employees of Edwards’ Analytical Limited or third parties hired by Edwards’ Analytical Limited carry out the Works in part or entirely on locations assigned by the Client, the Client will ensure that the health and safety regulations applicable to that location are communicated to the relevant Edwards’ Analytical Limited employees or third parties in a clear and timely manner. Employees of Edwards’ Analytical Limited and third parties hired by Edwards’ Analytical Limited are obliged to comply with these regulations.

10.2.     If the regulations about personal health and safety applied by Edwards’ Analytical Limited go further than the regulations applied by the Client, or if the employees of Edwards’ Analytical Limited or third parties hired by Edwards’ Analytical Limited believe additional safety norms should be considered, they are authorized to comply with the Edwards’ Analytical Limited regulations or the additional regulations. If the situation is such in the opinion of the Edwards’ Analytical Limited or third party that the Works cannot be carried out in a safe manner and the Client is unable or unwilling to apply sufficient measures, Edwards’ Analytical Limited has the right to suspend or terminate the Agreement in full or in part, without the Client having any right to damages

  1. 11.      Article 11 - Hiring Personnel

11.1.     The Client will not hire any employees of Edwards’ Analytical Limited that were involved in Works carried out under the Agreement for a period of at least two years after completion of the Works, without written permission from Edwards’ Analytical Limited.

  1. 12.      Article 12 - Force Majeure

12.1.  Edwards’ Analytical Limited cannot be held liable for permanent or temporary default, if such default is a result of force majeure, which includes situations like war, unrest, sabotage, labour unrest, strikes, fire, earthquakes, employee illness, accidents, compliance with government requests or orders.

If one of the abovementioned causes applies as a result of which Edwards’ Analytical Limited  us not able to fulfill its obligations for an uninterrupted period of at least (3) months, the Client has the right to terminate the Agreement with immediate effect, without the right of the Client to damages, Edwards’ Analytical Limited  has the right to claim payment from the Client for the Works carried out before the force majeure came into effect.

  1. 13.      Article 13 – Settlement

Edwards’ Analytical Limited, including all companies related to Edwards’ Analytical Limited through a concern, has the right to settle all amounts payable to it by the Client, including all companies related to the Client through a concern, with the amounts payable to the Client by Edwards’ Analytical Limited.

  1. 14.      Article 14 – Divisibility

14.1.  These General Conditions are considered divisible and if any provision in these general delivery conditions, for whatsoever reason, is or becomes invalid or inapplicable, the remaining provisions will remain in force. The invalid part of these Conditions will be considered replaced by stipulations that have the same effect, as far as is possible and allowed, as the invalid part.

  1. 15.      Article 15 – Applicable Law

15.1.  This Agreement is governed explicitly by English Law.

15.2.  Parties will refer any disputes in relation to this Agreement explicitly to the courts in England and Wales without prejudice to the right to appeal the decision of this court.

The Client declares, by accepting this document, that it has taken due note of the contents of these general conditions and agrees to them.

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