Analytical Testing of High Purity Water & Steam Systems

Specified chemical and microbiological analysis of samples is required at different stages of the water purification process to ensure the correct performance of separate equipment elements.

All the EP/USP and JP routine testing techniques are used including:-

• Total Organic Carbon (TOC) analysis

• Wet chemical tests for pre-treatment and purification assessment

• Quantitative Endotoxin (LAL) analysis

• Total Variable Count (TVC) analysis

• Absence of objectionable organisms

Full compliance to HTM2030 and HTM2031 for Dishwasher Disinfector Water and Clean Steam samples.

We also provide a full Continuous Compliance Assurance package (CCA), which collates analytical and plant performance, monitoring towards continuous inspection readiness.

Performance Qualification (PQ) Testing

We offer a full service, including development of testing rationales and protocols, chemical, microbiological, endotoxin analysis and validation summary reporting.

Microbiological Identification - Bacterial & Fungal

Using a wide range of traditional methods and utilising the Biomerieux API system, we have the expertise to identify a wide range of bacterial and fungal isolates to ensure continual microbial compliance of your systems and/or facilities.

BI Verification using our ISO Compliant Bier Vessel

Variability in BI performance arises during manufacture, handling, transportation and storage as well as differences in presentation during the sterilisation cycle and the recovery environment.  We offer an independent Biological Indicator testing service which includes the independent verification of D-value and population of commercially available BI’s and customised direct inoculation, such as the inoculation of stoppers and other equipment to D-Value assessments of product.  Our experience in sterilisation system design, optimisation and validation allows us to work with clients to agree on the best approach to each unique application.

Cleaning Validation Analysis

Our expert analytical and support services provide pharmaceutical manufacturers with a simple, cost effective method, to ensure primary manufacturing (API) and secondary production facilities meet regulatory requirements for cleaning process validation in order to minimise contamination or adulteration of drug products.  Developed specifically to your exacting requirements our package can encompass; protocol definition, rationale development, sampling methods, analysis, training and troubleshooting.

Disinfectant Efficacy

Our tailor made independent testing and support services will help you determine the quantitative value of bactericidal activity on all your cleanroom surfaces.  Tailored specifically to your requirements, we offer a complete package which includes the preparation of protocols which are applied using a range of organisms (including the typical environmental isolates found within your cleanroom environment) in accordance with the BS EN 13697 and USP <1072> regulatory requirements.

Environmental Monitoring

From practical advice and guidance in establishing an environmental monitoring programme within any cleanroom or production environment to the supply of quality controlled plates, incubation and analysis of samples and identification of organisms, our environmental monitoring services may also include an on-going assessment of microbial growth to determine the significance of bio-contamination.

Bio Burden Analysis

In order to demonstrate the effectiveness of control measures employed during the preparation and handling of components (for example, vials, ampoules, stoppers and tubes), equipment and removable machine parts prior to sterilisation, Honeyman offers a complete Bio Burden analysis service to quantify and identify the microbial bio burden.

Endotoxin Analysis (LAL Testing)

Whether raw materials, finished products, water or steam samples, Honeyman can analyse the presence of bacterial endotoxins using the Limulus Amoebocyte Lysate (LAL) test by employing the kinetic-turbidimetric instrumental method.  Endotoxin analysis is not only utilised in the testing of pharmaceutical products.  By utilising our expertise in endotoxin analysis we can work alongside our Validation specialists during the qualification of  depyrogenation equipment when demonstrating a log reduction of endotoxin. 

Microbial Limit Testing

We perform microbial limit testing in the determination of the number of viable aerobic micro-organisms and specific microbial species present in pharmaceutical articles including raw materials, primary, intermediate and finished products to ensure USP/EP compliance.  The method employed is developed and validated especially for your products, to specifically suit your requirements.

Preservative Efficacy Testing

In order to prevent problems arising from the microbial contamination of pharmaceutical products during the in-use shelf-life, it is a requirement to demonstrate that the anti-microbial activity of the product is adequate.  Honeyman are able to test pharmaceutical products including multi-dose injections, topical preparations and oral products using our EP and USP compliant methods.

Our highly trained personnel can carry out a range of sampling services on your site including water sampling and environmental monitoring.  Delivery of the samples to our laboratories may either be via a courier or our own validated transport.  The service fee includes the supply of sampling equipment such as bottles, labels and settle plates.

Over the last twenty years, thousands of delegates have benefited from our training courses and seminars, delivered on or off-site.  Up to date knowledge and experience derived from our extensive project and regulatory compliance work in the industry sets us apart from the plethora of training course providers in the marketplace.