Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
This aligns with the PDA body of work that correlates gas-flow behavior through micro-defects with maximum allowable leakage limits (MALL) and demonstrates that validated gas-flow measurements can be mapped to microbiological risk thresholds, thereby justifying air/nitrogen tests in use-cases that do not demand ultra-trace sensitivity.
“This aligns with the PDA body of work that correlates gas‑flow behavior through micro‑defects with maximum allowable leakage limits (MALL) (Hogreve 2023) and demonstrates that validated gas‑flow measurements can be mapped to microbiological risk thresholds, thereby justifying air/nitrogen tests in use‑cases that do not demand ultra‑trace sensitivity.”
From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as Hogreve 2023
Vendor and engineering-method documentation show that mass-flow approaches are particularly suited for higher-flow or large-volume components, while high-range mass-flow methods are specifically applied when large leaks are present and fine-defect sensitivity is less critical.
“Vendor and engineering‑method documentation show that mass‑flow approaches are particularly suited for higher‑flow or large‑volume components, while high‑range mass‑flow methods are specifically applied when large leaks are present and fine‑defect sensitivity is less critical (Hogreve 2023).”
From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as Hogreve 2023
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
No references could be resolved yet.
Research works printed but not linked: 15
- Aliaskarisohi, S.; Hogreve, M.; Langlois, C.; Cut- ting, J.; Barbaroux, M.; Cappia, J.-M.; Menier, M.-C. Single-Use System Integrity I: Using a Micro- bial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL). PDA J. Pharm. Sci. Technol. 2019, 73 (5), 459-469.
- Aliaskarisohi, S.; Kumar, C.; Hogreve, M.; Montenay, N.; Cutting, J.; Mundrigi, A.; Para- mathma, A. Single-Use System Integrity II: Characterization of Liquid Leakage Mechanisms. PDA J. Pharm. Sci. Technol. 2021, 75 (3), 258- 272.
- Aliaskarisohi, S.; Urbaniak, T.; Hogreve, M. Sin- gle-Use System Integrity III: Gas Flow Rate through Laser-Drilled Microchannels in Polymeric Film Mate- rial. PDA J. Pharm. Sci. Technol. 2022, 76 (1), 9-18.
- Chen, C.; Harte, B.; Lai, C.; Pestka, J.; Henyon, D. Assessment of Package Integrity Using a Spray Cabinet Technique. J. Food Prot. 1991, 54 (8), 643- 647.
- Kirsch, L. E.; Nguyen, L.; Moeckly, C. S. Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 187- 194.
- Nguyen, L. T.; Muangsiri, W.; Schiere, R.; Guazzo, D. K. M.; Kirsch, L. E. Pharmaceutical Container/Closure Integrity IV: Development of an Indirect Correlation between Vacuum Decay Leak Measurement and Microbial Ingress. PDA J. Pharm. Sci. Technol. 1999, 53 (4), 211-216.
- Burell, L. S.; Carver, M. W.; DeMuth, G. E.; Lambert, W. J. Development of a Dye Ingress Method to Assess Container-Closure Integrity: Cor- relation to Microbial Ingress. PDA J. Pharm. Sci. Technol. 2000, 54 (6), 449-455.
- Gilchrist, J. E.; Rhea, U. S.; Dickerson, R. W.; Campbell, J. E. Helium Leak Test for Micron-Sized Holes in Canned Foods. J. Food Prot. 1985, 48 (10), 856-860.
- Bankes, P.; Stringer, M. F. The Design and Application of a Model System to Investigate Physical Factors Affecting Container Leak- age. Int. J. Food Microbiol. 1988, 6 (4), 281- 286.
- Gilchrist, J. E.; Shah, D. B.; Radle, D. C.; Dicker- son, R. W. Jr. Detection in Flexible Retort Pouches. J. Food Prot. 1989, 52 (6), 412-415.
- Keller, S. W.; Marcy, J. E.; Blakistone, B. A.; Lacy, G. H.; Hackney, C. R.; Carter, W. H. Jr. Bioaerosol Exposure Method for Package Integ- rity Testing. J. Food Prot. 1996, 59 (7), 768- 771.
- Moghimi, N.; Kim, S.-J.; Park, S.-I. Assessing of Flexible Packaging Integrity: Using the Aeroso- lization Bacteria. Packag. Technol. Sci. 2016, 29 (3), 135-143.
- Moghimi, N.; Park, S.-I. Leakage Assessment of Flexible Pouches Using Dye Penetration Test with Correlation to Modeled Bacterial Aerosol Challenge Test. Food Sci. Biotechnol. 2017, 26 (4), 947-953.
- Mala, G. M.; Li, D. Flow Characteristics of Water in Microtubes. Int. J. Heat Fluid Flow 1999, 20 (2), 142-148.
- U.S. Pharmacopeial Convention, General Chapter <1207> Sterile Product Packaging -Integrity Evalu- ation. In USP 39-NF 34, USP: Rockville, MD, 2016.
Cited by
Sorted by citations
Single-use solutions for PUPSIT: requirements, challenges, and solutions
Glenz, M., Eiermann, P., Manser, B., & Teschner, H. (2026) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-026-13847-5 · Cited by 1 · see citing works
- Authors
- Hogreve, M.
- Venue
- PDA Journal of Pharmaceutical Science and Technology
- Publisher
- Parenteral Drug Association, Inc.
- Published
- 2022-12-26
- Volume
- 77
- Issue
- 2
- Pages
- 133-144
- ISSN
- 1079-7440
- 1948-2124
- Cited by
- 1
- References
- 0
- Language
- en
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
