| Would switching most bioprocessing streams to | | | | with requests from numerous companies wanting to |
| disposable components be a net positive or negative | | | | start studies on the successes and failures of |
| proposition for the environment? Which bioprocesses | | | | single-use systems. One area where research has |
| can feasibly be moved toward the use of | | | | increased markedly in order to give disposables even |
| disposables? | | | | higher acceptance is in the testing for detection of |
| The scale of disposable process streams in great part | | | | extractables and leachables from the plastic materials |
| determines how possible it is to incorporate | | | | which they are made of. Most are made from |
| disposable components. Highly bioactive compounds, | | | | polyethylene film that is low in extractables and |
| personalized medicines or small clinical batches - all | | | | leachables. |
| small volume production streams - can be done in | | | | Current challenges, though, include the lack of |
| disposable systems from beginning to end. However, | | | | standardization for disposable ports and connectors. |
| any large-scale production, for example 10,000 to | | | | Producers are trying to standardize their systems on |
| 20,000 liter batches of monoclonal antibodies cannot | | | | a few select tubing sizes or rely on customized |
| be made entirely with disposable components - at | | | | products. However, today it's likely that most of |
| least not economically. Anything in between the | | | | them will have to work with a dozen or more |
| largest scale and the smallest scale can be worked | | | | manufacturers of disposable products in order to |
| out using hybrid systems that combine disposable and | | | | accomplish their production objectives. |
| fixed elements. | | | | For example, the transfer of sterile fluids between |
| As far as the environmental question is concerned, | | | | steamable, hard-piped processing systems and |
| one would think that disposable bags containing | | | | sterilized disposable systems is an area where several |
| remnants of chemicals and other hazardous | | | | manufacturers have concentrated by creating a 1 |
| substances could not possibly be good for the | | | | inch standard connector. |
| environment, however, the net effect of using | | | | A lot of work lies ahead, but the trend toward |
| disposables is quite positive. The FDA has examined | | | | expanded use of disposable systems is well |
| single-use manufacturing components and has not | | | | established and the entrepreneurial phase of this |
| found the need for any new regulation or guidance | | | | industry is coming to maturity. Standardization, |
| over its use. This may seem impossible to those who | | | | increases in volume handling, and elimination of |
| are skeptical about government, but the fact is that, | | | | leachables/extractables risk are three areas where |
| from a regulatory perspective, these equipments | | | | manufacturers are concentrating in order to make |
| represent better containment and lower risk of | | | | single-use systems an easier alternative for every |
| batch-to-batch contamination, among other benefits. | | | | bioprocessor. |
| Single-use manufacturing techniques also make it | | | | If you enjoyed this article about a pharmaceutical |
| easier to dispose of a lot of the hazardous and toxic | | | | consultants, please feel free to post it to your site or |
| materials that are usually tougher to clean out from | | | | blog and forward this link to to your friends. Have a |
| process lines. | | | | great day! |
| Pharmaceutical consultants have had their plate full | | | | |