As a smaller manufacturer of prepared media, Cherwell has the agility to produce smaller batches of media, and is able to develop products that meet a customer’s specific requirements.
Requests for bespoke culture media products can vary significantly. They range from a relatively straight forward request for an existing product in a new media fill volume or packaging variant, to more complicated requests for products requiring the use of new formulations.
Any growth media New Product Request (NPR) received will be categorised into one of three risk levels: Low, Medium or High. The risk level is dependent on the complexity of the requested product.
* Timeline begins after the NPR has been accepted / agreed for development and does not include the initial consultative period.
The NPR process is initiated upon receiving a request from a customer following initial discussion with one of Cherwell’s Business Development Managers. During the discussion, pre-assessment of the commercial feasibility of the request will be conducted. This will determine whether the prepared media product fits Cherwell’s product profile, the quantity required, gain greater understanding of the customer’s process requirements, and any other relevant details.
This could be followed by an arrangement to further discuss technical details with the Microbiology Product Specialist to ensure that all the required details are specified in the NPR documentation.
It is also important to note that there is a potential project fee associated with all new product developments; if a fee is applicable, it will be communicated to the customer before progressing with development of the new product.
Pre-qualified NPRs will be assigned the appropriate risk level category. All high-risk NPRs will be subject to further approval by Cherwell’s product steering group panel before proceeding.
In some cases, prior to pre-qualification, an initial small test could be initiated as an early indication of the feasibility of manufacturing. For example, the NPR may require media to be filled into a particular type of container used by the customer; in this case, the small test could involve obtaining a sample of these containers from the customer to check the feasibility of the filling process.
Upon approval, the NPR proposal will generally progress through the business in the stages explained in the video below:
The NPR process generally follows the sequence described in the video. However, the process is fluid. It is therefore, possible that, as a new product progresses, it may revert to an earlier stage of the process, depending on the outcome of one of the stages, or feedback received.
For example, if a trial product indicates inconsistency in pH, the NPR status will revert to an earlier stage for consideration of the formulation’s suitability and/or required pH adjustments before the product again moves through the subsequent stages.
Although a lot of work is involved, the process of developing a NPR at Cherwell is well-oiled. As a result, a low-risk request, such as an existing formulation in a new packaging format, could be available to order in less than a month.
Our experience at Cherwell means that even more complex requests, such as completely new formulations, are not delayed. More importantly, in all stages following the initial enquiry, the appropriate considerations are made to ensure the development of high-quality product that is right for the customer and fit for purpose.
To discuss bespoke culture media and a Redipor formulation that meets your specific requirements, fill out the New Product Request form, or contact our team for more information.
