Assessing the Risk of Leachables from Single-Use Systems - This article is the second in a two-part series on extractables and leachables. - BioPharm International

ADVERTISEMENT

Assessing the Risk of Leachables from Single-Use Systems
This article is the second in a two-part series on extractables and leachables.


BioPharm International
Volume 25, Issue 2, pp. 32-40

CONCLUSION

The data presented indicate there is little risk from leachables when using single-use systems. The QbD methodology used to identify materials ensures incorporation of components with low aqueous solubilities, materials cleared as food contact substances by FDA, and materials qualified as Class VI by USP.

The low concentrations of leachables that do enter into the product should not affect drug performance or quality-control tests.

As shown in the first case study, if the leachable is introduced upstream, the clarification process will reduce the concentration below the limit of concern. Realistic working conditions allow the level of leachables to fall below the threshold of concern for genotoxic compounds.

The second case study demonstrates that the concentration of leachables from the final formulation and fill–finish assemblies do not pose a risk to patients because concentrations are well below the TTC.

Paul F. Killian, PhD, is a senior research scientist in the analytical technologies group at EMD MIllipore, Bedford, MA,
.

REFERENCES

1. C.M. Hansen, Hansen Solubility Parameters: A User's Handbook (Taylor & Francis, Boca Raton, FL, 2nd ed., 2007).

2. ExxonMobil Chemical, Tips From Technology—Slip and Anti-Block Additives in Polyethylene Film (2003).

3. EPA database, iaspub.epa.gov/opthpv/Public_Search.PublicTabs?SECTION=1&epcount=1&v_re_list=25063720/, accessed Fan 23, 2011.

4. FDA Regulatory Information, http://www.fda.gov/RegulatoyInformation/Legislation/FederalFoodDrugandCosmeticAct/

FDCActChapterIVFood/ucm107843.htm, accessed Jan. 23, 2011.

5. About USP, http://www.usp.org/aboutUSP/ accessed July 9, 2009.

6. http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContactSubstancesFCS/CEDIADIDatabase/default.htm, accessed Jan. 23, 2011.

7. G.M. Cramer et al, Food Cosmet. Tox. 16 (3), 255–276 (1976).

8. R. Kroes et al., Food Chem. Toxicol. 42 (1), 65–83 (2004).

9. Millipore Corporation, Extractables Testing Report PureFlex and SureFlex Disposable Process Container Films, White Paper (2009).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here