Over the years, Remsol has worked extensively with the UK pharmaceutical industry and has developed an impressive track-record for delivering added value and long-term environmental improvements. With a sound understanding of the constraints that stem from current Good Manufacturing Practice (cGMP) as enshrined in CFR21 and the Orange Guide, we have been able to help our pharmaceutical clients get the most from their waste management arrangements whilst still ensuring compliance with the regulatory codes that govern pharmaceutical manufacturing practices.
Process improvements yield significant waste savings
A pharmaceutical manufacturer in the North West of England benefitted from Remsol's unique approach to problem solving and saved over £100,000 in costs.
During a process improvements review conducted by the Remsol team on site, it was discovered that stainless steel manufacturing vessels were being washed and sanitised when they still contained up to 5 litres each of valuable product, instead of being cleaned only when they were empty. Remsol identified that the problem stemmed from incompatibility of lids and tanks.
Once this was resolved, with the correct lids fitted to the correct tanks at all times, only minor residues of finished product were left behind and lost to waste.
This relatively simple change enabled the client to reduce its standard manufacturing costs by over £100,000 but the success didn't end there: by capturing these large quantities of finished product, the client was able to get more of its seasonal product onto the shelves earlier in its key markets, leading to opportunity cost savings of more than £1m a year.
Re-designation of waste reduces incineration costs
A pharmaceutical Contract Manufacturing Organisation (CMO) situated in the South West of England had been consigning waste to high temperature incineration for many years, describing it as "secure pharmaceutical waste".
Remsol was able to establish that the waste contained very little finished pharmaceutical product and was in fact more akin to clinical waste arising in hospitals and surgeries.
Negotiations with a clinical waste incinerator commenced, and soon agreement was reached for the waste to be processed at their facility near London at rates that offered a substantial cost advantage over previous arrangements.
The Remsol team on site has since identified that much of the waste currently being incinerated is not contaminated at all, and a process is underway to begin diverting these non-hazardous fractions for alternative disposal and recycling in an effort to further reduce reliance on expensive incineration.
WFI vials no longer a weighty contributor to expensive incineration costs
A company in the North West of England that specialises in the manufacture of sterile, injectable pharmaceuticals, had been discarding glass vials in 205L drums for expensive high temperature incineration.
As part of a wider waste audit, Remsol's on site team was able to establish that, contrary to the clients' accepted understanding, the vast majority of these vials contained nothing more than Water For Injection (WFI) from line set-up trials and therefore did not require destruction by incineration.
Working together, Remsol and the client subsequently developed and implemented a segregation system for the water filled vials that saw these collected in a separate infrastructure. These were then collected from site in skips, free of charge, by a nationwide glass recycler and processed into fibreglass products.
The WFI content posed no problem, as it quickly evaporated in the recycling process as the glass was melted at high temperature.
Overall, this simple change reduced the clients' exposure to incineration by more than £8,000 a year as well as saving drum purchasing costs.
Waste oil bulking process delivers waste savings and storage improvements
A contract manufacturer of pharmaceuticals in the South of England was generating waste machine oils in 25 litre plastic drums, which were disposed of via a waste transfer station.
Bunded storage on the site was very limited, and improvements were being sought as part of efforts to reduce spill risks associated with storing liquid waste in containers. Disposal costs were also under the microscope.
In the provision of a bundled, waste management outsourcing contract to the client, Remsol decided to tackle these issues head on and set about designing and manufacturing a bespoke decanting facility through which the waste oils could be bulked-up from the small 25 litre containers and into a single 1,000 litre IBC instead.
After several months of design effort aimed at making the process as safe and as easy to use as possible, the decanting facility finally made it to site in the summer of 2009.
The unit immediately delivered the benefits needed: with bunded storage available for the IBC, bulking-up from the smaller containers every day now means that the spillage risks associated with storing waste oil in numerous small drums have been practically eliminated. And, the costs of disposal have also fallen significantly from the equivalent of £0.60p per litre to just £0.09p per litre - a welcome saving of 60%
Once suitable earthing arrangements and ventilation are in place, the decanting facility will also be used to bulk-up laboratory solvent wastes from 2.5 litre bottles and into 205 litre drums to deliver even more significant cost reductions.