Research ArticleResearch
Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements
Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello and Stefanie Funke
PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 474-489; DOI: https://doi.org/10.5731/pdajpst.2020.012567
Safia Lotfi
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
Fabio Montagner
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
Christian Proff
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
Sascha Dreher
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
Ulla Grauschopf
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and
Chiara De Zorzi
2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy
Odra Pinato
2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy
Serena Panighello
2SG Lab Analytics, Nuova Ompi, Stevanato Group, Padova, Italy
Stefanie Funke
1F. Hoffmann-La Roche Ltd, Device and Packaging Development, PTD Biologics Europe (PTDE-D), Basel, Switzerland; and

References
- 1.↵
- Rios M.,
- Harrison B.
- 2.↵
- Ingle R. G.,
- Agarwal A. S.
- 3.↵
- Sassalos T. M.,
- Paulus Y. M.
- 4.↵
- Sardella A.
- 5.↵
- Petersen C.,
- Fries A.,
- Zeiss B.
- 6.↵
- Santucci-Aribert V.,
- Rossito E.
- 7.↵
- Lawson S.,
- Flannigan C.,
- Green C.,
- Freeburn L.,
- Burns A.,
- McCann J.,
- Bourke T.
- 8.↵
- Polin J. B.
- 9.↵
- Makwana S.,
- Basu B.,
- Dharamsi A.,
- Makasana Y.
- 10.↵
- Loosli V.,
- Germershaus O.,
- Steinberg H.,
- Dreher S.,
- Grauschopf U.,
- Funke S.
- 11.↵
- 12.↵
- Gerhardt A.,
- Nguyen B. H.,
- Lewus R.,
- Carpenter J. F.,
- Randolph T. W.
- 13.↵
- Funke S.,
- Matilainen J.,
- Nalenz H.,
- Bechtold-Peters K.,
- Mahler H.-C.,
- Vetter F.,
- Müller C.,
- Bracher F.,
- Friess W.
- 14.↵
- Sacha G.,
- Rogers J. A.,
- Miller R. L.
- 15.↵
- Nashed-Samuel Y.,
- Liu D.,
- Fujimori K.,
- Perez L.,
- Lee H.
- 16.↵
- Funke S.,
- Matilainen J.,
- Nalenz H.,
- Bechtold-Peters K.,
- Mahler H. C.,
- Friess W.
- 17.↵
- Thornton J. D.,
- Jonsen D. E.,
- Sakhrani V.
- 18.↵
- Jezek J.,
- Darton N. J.,
- Derham B. K.,
- Royle N.,
- Simpson I.
- 19.↵
- Sluzky V.,
- Tamada J. A.,
- Klibanov A. M.,
- Langer R.
- 20.↵
- 21.↵
- Chan E.,
- Hubbard A.,
- Sane S.,
- Maa Y.-F.
- 22.↵Parenteral Drug Association Inc. Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications; PDA: Bethesda, MD, 2015.
- 23.↵
- Reuter B.,
- Petersen C.
- 24.↵
- Funke S.,
- Matilainen J.,
- Nalenz H.,
- Bechtold-Peters K.,
- Mahler H. C.,
- Friess W.
- 25.↵
- Funke S.
- 26.↵
- Bee J. S.,
- Frey V. V.,
- Javed U.,
- Chung J.,
- Corcoran M. L.,
- Roussel P. S.,
- Krause S. O.,
- Cash P. W.,
- Bishop S. M.,
- Dimitrova M. N.
- 27.↵European Committee for Standardization. EN ISO 11040-4:2015 Prefilled syringes—Part 4: Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling. 2015.
- 28.↵
- Wen Z. Q.,
- Vance A.,
- Vega F.,
- Cao X.,
- Eu B.,
- Schulthesis R.
- 29.↵
- 30.↵
- 31.↵
- Clifton P. A.
- 32.↵
- Khandke L.,
- Malone R.,
- Yang X.,
- H. Han H.,
- Look J. L.,
- Jin Z.,
- Seid R. C.,
- Chen J. R. Y.
- 33.↵
- Rößler R.
- 34.↵
- 35.↵
- Buddrick O.,
- Jones O. A. H.,
- Morrison P. D.,
- Small D. M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements
Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello, Stefanie Funke
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 474-489; DOI: 10.5731/pdajpst.2020.012567
Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements
Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello, Stefanie Funke
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 474-489; DOI: 10.5731/pdajpst.2020.012567
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.