Procedures and responsibilities for new Redipor products
As a smaller manufacturer of prepared media, at Cherwell we’re able to produce small batches of tailored media or buffers to the customer’s individual specification.
Customer requests are all very different, and a “new product” can be an existing formulation in a container or fill quantity we haven’t produced before, or a completely new formulation. A customer might want a version of TSA and the enzyme β Lactamase in flow wrap packaging, or a specific formulation of buffered peptones, both with and without specific neutralisers.
The new product process starts with your Business Development Manager, who confirm the formulation, packaging, and QC testing requirements with the customer. For a brand new formulation, the feasibility of production has to be determined. There are several things to consider:
- Are the necessary materials available?
- Is a risk and COSHH assessment necessary?
- Is the product safe to manufacture?
- Are we able to perform the requested QC tests?
If production’s considered feasible, the next stage will be costing. To do this, we calculate the cost of the necessary raw materials, equipment usage, the amount of time the process is likely to take, as well as packaging, labels and QC testing. A product code’s then generated, and sent to the customer along with a product specification and quote.
Once confirmed with the customer, we generate the relevant documentation, such as a new or amended product specification sheet and certificate of analysis. This documentation then goes to QA and production, where a decision will be made regarding whether we need to produce a trial batch to generate more data for the product specification sheet. This includes details such as appearance, and how the product performs during growth promotion testing.
QC will comment on the strength of the agar and any other noteworthy characteristics that might need to be included on the product spec sheet. Any problems will be communicated to the customer. Shelf life will be discussed with the customer before the product’s assigned.
If all’s well following a trial, the manufacturing records and packing sheets for the batch are generated by production, and the final specification sheet confirmed by our Quality Assurance team. QA will also run through all the documentation with a fine-tooth comb. When the QA department’s satisfied, the documentation is passed to Andy Whittard, Cherwell’s Managing Director, for authorisation.
Although there’s a lot of work involved, development of a new product request is a well-oiled process. This means that in the case of a low-risk request, such as an existing formulation in new packaging, the product could be available to order in as little as a couple of weeks. Even with more complex requests, such as completely new formulations, our experience at Cherwell means the process isn’t delayed. But our focus is always ensuring that the product is right for the customer.
If you’d like to discuss a new product, please contact us to discuss your specific requirements.
