Regulatory pressures on microbial drug production means big wins for Cherwell Laboratories
The expansion, which boosts the facility from 440m sq to over 940m sq, includes a new inspection room which runs 100 per cent QC (quality control) of the media before packaging. A cleanroom packaging area and extra warehouse space has also been added.
The plant will focus on production of the Redipor media line, which includes products such as gamma irradiated media, bottled media, and broth bags for bio drugsmakers.
“The new cleanroom facility gives us an even higher degree of flexibility and ability to react quickly to our customers’ specific needs,” managing director Andy Whittard told in-PharmaTechnologist.com.
He told us the move follows a 25 per cent uptick in sales this year for Cherwell’s prepared media, a figure the firm expects will grow further in coming years because of increasing regulatory pressures on microbial producers.
“We believe that this growth is due to the fact that the demands on the pharmaceutical industry for more environmental monitoring are ever increasing as the regulators continually revise their interpretation of contamination risk,” Whittard said.
Cherwell is currently working on the second phase of its cleanroom expansion – expected to hit completion in 2013 – which will boost media production, particularly for agar plates. The firm says additions will lift agar production from 5.5m plates now to 6.5 next year.
The extra mile
In a bid to outperform regulatory requirements, the company will use the extra warehousing space to house products going through a holding period for QA (quality assurance).
“Uniquely, we do not package our media products straight off the end of the filling line, instead all products undergo a holding period to allow them to condition,” Whittard said.
“This avoids excessive condensation in the final pack, meaning that Redipor products are always of the utmost quality, ensuring ease of handling and use.”
He added that he believes a 100 per inspection of all prepared media before final packing is unique to Cherwell, and “further ensures high quality and customer confidence to use Redipor prepared media within critical areas.”