References

 
 

Leading Facts

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References in ApiJect Materials

Gavi Mid-Term Meeting

  1. Immunization coverage reaches 84%, still short of 90% goal, WHO, 17 July 2014, http://www.who.int/immunization/newsroom/press/immunization_coverage_july2014/en/

  2. The burden of unsafe injections worldwide: highlights on recent improvements and areas requiring urgent attention, WHO, Benedetta Allegranzi, Lead, Clean Care is Safer Care programme, WHO Service Delivery and Safety, HQ, http://www.who.int/medical_devices/Sun_pm_SAF_2_ALLEGRANZI.pdf

  3. Challenges and Innovations in Vaccine Delivery, 10th Annual African Vaccinology Course (AAVC): Developing Vaccinology Expertise for Africa, 10–14 November 2014, Cape Town, South Africa, PATH, Darin Zehrung, Senior Technical Officer and Portfolio Leader, Delivery Technologies, Vaccine and Pharmaceutical Technologies Group, 13 November 2014.

  4. Blow-Fill-Seal: An Advanced Aseptic Packaging Technology, Andrew W. Goll, https://www.healthcarepackaging.com/sites/default/files/whitepaper/WeilerEbook_V5.pdf

  5. Ibid / U.S. Energy Information Administration, Glass manufacturing is an energy-intensive industry, mainly fueled by natural gas, August 21, 2013, https://www.eia.gov/todayinenergy/detail.php?id=12631.

  6. Can a Compact Pre-Filled Auto-Disable Injection System (cPAD) Save Costs for DTP-HepB-Hib Vaccine as Compared with Single-Dose (SDV) and Multi-Dose Vials (MDV)? Evidence from Cambodia, Ghana, and Peru, Drugs Real World Outcomes, 2015 Mar; 2(1): 43–52, Cyril Nogier, Patrick Hanlon, Karin Wiedenmayer, Nicolas Maire.

    Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats, Vaccine, 2018 Mar 14; 36(12): 1700–1709, Jeff Sedita, Stefanie Perrell, Matt Morio, Michael Berbari, Jui-Shan Hsu, Eugene Saxon, Courtney Jarrahian, Annie Rein-Weston, and Darin Zehrung.

    Pentavalent Vaccine in the Uniject™ Injection System: Health Care Waste Management Consideration, PATH, Adriane Berman, MPH, and Nancy Muller, MA, and with input from Lyndsey Kostadinov, BSc, at Crucell Switzerland AG, September 31, 2014.

    Delivery cost analysis of a reactive mass cholera vaccination campaign: a case study of Shanchol™ vaccine use in Lake Chilwa, Malawi. BMC Infect Dis. 2017; 17: 779, Patrick G. Ilboudo and Jean-Bernard Le Gargasson, December 19, 2017.

    DTwP-HepB-Hib vaccine available in a compact, pre-filled auto-disable injection technology, WHO and UNICEF, March 2015

 

(Red Booklet)

Low-Cost Mono-Dose Syringes Enable Many Use Cases for Global Impact

  1. https://www.sciencedirect.com/science/article/pii/S0264410X18300355

  2. https://www.businesswire.com/news/home/20170508005585/en/Collaboration-Helps-Broaden-Access-Pfizer%E2%80%99s-Contraceptive-Sayana%C2%AE

  3. PATH. Pentavalent Vaccine in the Uniject ™ Injection System: a Time and Motion Study. Seattle: PATH; 2014.

  4. http://www.who.int/en/news-room/fact-sheets/detail/family-planning-contraception

  5. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  6. Ibid

  7. Ibid

  8. https://qz.com/239281/how-this-smart-contraceptive-design-could-liberate-women-in-africa/

  9. http://1millionhealthworkers.org/data-for-decision-making/

  10. World Health Organization, 2011. World Health Statistics 2011 - Table 6: Health workforce, infrastructure and essential medicines. Accessed 21 July 2011.

  11. p. 20 of One Million Community Health Workers Campaign’s Annual Report 2014: Building Healthy Communities by Bringing CHWs to Scale (Published on Mar 12, 2015). https://issuu.com/1millionhealthworkers/docs/annualreport2014

  12. http://www.who.int/en/news-room/fact-sheets/detail/maternal-mortality

  13. Ibid

  14. Ibid

  15. Ibid

  16. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  17. Ibid

  18. https://www.poz.com/article/longacting-injectable-hiv-meds-suit-study-participants

  19. Ibid

  20. Ibid

  21. http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/Key_mess_FAQs.pdf

  22. https://www.lifescienceleader.com/doc/what-you-should-know-about-blow-fill-seal-0001

  23. Ibid

  24. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777640/

  25. https://www.acsh.org/news/2018/02/02/influenza-vaccination-global-not-same-12504

  26. Ibid

  27. https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2017.htm

  28. https://www.abc27.com/health/health-center/cost-and-accessibility-differences-between-narcan-and-epipens/1105043253

  29. http://www.who.int/immunization/programmes_systems/supply_chain/optimize/Intradermal-delivery-vaccines_report_2009-Sept.pdf

  30. https://www.farmersweekly.co.za/farm-basics/how-to-livestock/injecting-animals-part-1/

 

(Red Booklet)

ApiJect’s 32 “Soft Benefits” are Difficult to Measure, but Improve Lives in Many Ways

  1. http://www.chop.edu/centers-programs/vaccine-education-center/global-immunization/diseases-and-vaccines-world-view

  2. http://1millionhealthworkers.org/data-for-decision-making/

  3. World Health Organization, 2011. World Health Statistics 2011 - Table 6: Health workforce, infrastructure and essential medicines. Accessed 21 July 2011.

  4. p. 20 of One Million Community Health Workers Campaign’s Annual Report 2014: Building Healthy Communities by Bringing CHWs to Scale (Published on Mar 12, 2015). https://issuu.com/1millionhealthworkers/docs/annualreport2014

  5. http://www.who.int/en/news-room/fact-sheets/detail/family-planning-contraception

  6. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  7. Ibid

  8. Ibid

  9. PATH. Pentavalent Vaccine in the Uniject ™ Injection System: a Time and Motion Study. Seattle: PATH; 2014.

  10. https://qz.com/239281/how-this-smart-contraceptive-design-could-liberate-women-in-africa/

  11. World Health Organization. Family Planning/Contraception Fact Sheet. Available at: http://who.int/mediacentre/factsheets/fs351/en/. Accessed: February 22, 2017.

  12. WHO, Environmental Burden of Disease Series, No. 3, Annette Prüss-Üstün, Elisabetta Rapiti, Yvan Hutin, Sharps injuries: Global burden of disease from sharps injuries to health-care workers, 2003

  13. Ibid

  14. http://apps.who.int/medicinedocs/documents/s15946e/s15946e.pdf

  15. PATH, Challenges  and  Innovations in Vaccine  Delivery, 10th  Annual  African  Vaccinology  Course  (AAVC): Developing Vaccinology  Expertise  for  Africa, 10–14  November  2014  Cape  Town,  South  Africa, by Darin Zehrung, Senior  Technical  Officer and Portfolio  Leader, Delivery Technologies, Vaccine  and  Pharmaceutical Technologies Group, 13 November 2014

  16. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875254/

  17. http://www.pharmtech.com/testing-glass-flakes-pharmaceutical-vials

  18. Ibid

  19. Human Vaccines Journal, 01 Mar 2010, Volume 6, 2010 – Issue 3, Pages 270-278, Impact of Wastage on Single and Multi-dose Vaccine Vials: Implications for Introducing Pneumococcal Vaccines in Developing Countries, Divya Parmar, Elaine M. Baruwa, Patrick Zuber & Souleymane Kone.

    Vaccine Wastage Assessment, UNICEF, April 2010, Field assessment and observations from National stores and five selected states of India.

  20. Tiwari, Ranjana & Dwivedi, Shatkratu & Swami, Piyush & Mahore, Rakesh & Tiwari, Sakshi. (2017). A study to assess vaccine wastage in an immunization clinic of tertiary care centre, Gwalior, Madhya Pradesh, India. International Journal of Research in Medical Sciences. 5. 2472. 10.18203/2320-6012.ijrms20172431. https://www.researchgate.net/publication/317197954_A_study_to_assess_vaccine_wastage_in_an_immunization_clinic_of_tertiary_care_centre_Gwalior_Madhya_Pradesh_India, accessed 08/24/18.

    Vaccine. 2017 Dec 4;35(48 Pt B):6751-6758. doi: 10.1016/j.vaccine.2017.09.082. Epub 2017 Oct 21. https://www.ncbi.nlm.nih.gov/pubmed/ 29066189. Accessed 08/24/18.

  21. https://www.sciencedirect.com/science/article/pii/S0264410X18300355

  22. World Health Organization, WHO Best Practices for Injections and Related Procedures Toolkit, March 2010

  23. https://www.fda.gov/downloads/drugs/guidances/ucm389069.pdf

  24. https://www.lifescienceleader.com/doc/what-you-should-know-about-blow-fill-seal-0001

  25. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  26. Ibid

  27. World Health Organization. “General Information on Counterfeit Medicines,” WHO website posting, 2015. Last accessed 18 February 2015.

  28. World Health Organization. “General Information on Counterfeit Medicines,” WHO website posting, 2015. Last accessed 18 February 2015.

  29. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00394-3/fulltext?code=lancet-site

  30. https://www.rommelag.com/en/engineering/bfs/

  31. https://www.farmersweekly.co.za/farm-basics/how-to-livestock/injecting-animals-part-1/

  32. https://www.eia.gov/todayinenergy/detail.php?id=12631

  33. Ibid

  34. Ibid

  35. https://academicjournals.org/article/article1380362493_Isa%20Pdf.pdf

  36. http://www.agc-glass.eu/en/sustainability/environmental-achievements/environmental-impact

  37. 2011. Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics. IPQ in the News.

  38. https://www.ipqpubs.com/news/sharp-uptick-in-recalls-for-glass-lamellae-problems-under-scrutiny/

  39. Ibid

 

 

(Red Booklet)

Billions of Glass Vials Every Year with Unintended Consequences

  1. https://www.sciencedirect.com/science/article/pii/S0264410X18300355

  2. Ibid

  3. http://1millionhealthworkers.org/data-for-decision-making/

  4. World Health Organization, 2011. World Health Statistics 2011 - Table 6: Health workforce, infrastructure and essential medicines. Accessed 21 July 2011.

  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5611431/

  6. Ibid

  7. p. 20 of One Million Community Health Workers Campaign’s Annual Report 2014: Building Healthy Communities by Bringing CHWs to Scale (Published on Mar 12, 2015). https://issuu.com/1millionhealthworkers/docs/annualreport2014

  8. World Health Organization. “General Information on Counterfeit Medicines,” WHO website posting, 2015. Last accessed 18 February 2015.

  9. World Health Organization. “General Information on Counterfeit Medicines,” WHO website posting, 2015. Last accessed 18 February 2015.

  10. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00394-3/fulltext?code=lancet-site

  11. http://apps.who.int/medicinedocs/documents/s15946e/s15946e.pdf

  12. PATH, Challenges  and  Innovations in Vaccine  Delivery, 10th  Annual  African  Vaccinology  Course  (AAVC): Developing Vaccinology  Expertise  for  Africa, 10–14  November  2014  Cape  Town,  South  Africa, by Darin Zehrung, Senior  Technical  Officer and Portfolio  Leader, Delivery Technologies, Vaccine  and  Pharmaceutical Technologies Group, 13 November 2014

  13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3875254/

  14. http://www.pharmtech.com/testing-glass-flakes-pharmaceutical-vials

  15. Ibid

  16. 2011. Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics. IPQ in the News.

  17. https://www.ipqpubs.com/news/sharp-uptick-in-recalls-for-glass-lamellae-problems-under-scrutiny/

  18. Ibid

  19. https://qz.com/239281/how-this-smart-contraceptive-design-could-liberate-women-in-africa/

  20. World Health Organization. Family Planning/Contraception Fact Sheet. Available at: http://who.int/mediacentre/factsheets/fs351/en/. Accessed: February 22, 2017.

  21. https://www.businesswire.com/news/home/20170508005585/en/Collaboration-Helps-Broaden-Access-Pfizer%E2%80%99s-Contraceptive-Sayana%C2%AE

  22. PATH. Pentavalent Vaccine in the Uniject ™ Injection System: a Time and Motion Study. Seattle: PATH; 2014.

  23. http://www.agc-glass.eu/en/sustainability/environmental-achievements/environmental-impact

  24. Ibid

  25. https://academicjournals.org/article/article1380362493_Isa%20Pdf.pdf

  26. https://www.eia.gov/todayinenergy/detail.php?id=12631

  27. Ibid

  28. Ibid

  29. WHO, Environmental Burden of Disease Series, No. 3, Annette Prüss-Üstün, Elisabetta Rapiti, Yvan Hutin, Sharps injuries: Global burden of disease from sharps injuries to health-care workers, 2003

  30. Ibid

  31. Tropical Medicine and International Health, volume 18 no 8 pp 1002-1017 August 2013, C. Glenton, et al., Acceptability of CPADS delivered by lay health workers

 

 

(Red Booklet)

How a Low-Cost Mono-Dose Syringe Can Increase Safety and Coverage

  1. Can a Compact Pre-Filled Auto-Disable Injection System (cPAD) Save Costs for DTP-HepB-Hib Vaccine as Compared with Single-Dose (SDV) and Multi-Dose Vials (MDV)? Evidence from Cambodia, Ghana, and Peru. Cyril Nogier, Patrick Hanlon, Karin Wiedenmayer, Nicolas Maire. January 29 2015.

    Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats. Jeff Sedita, Stefanie Perrell, Matt Morio, Michael Berbari, Jui-Shan Hsu, Eugene Saxon, Courtney Jarrahian, Annie Rein-Weston, and Darin Zehrung. Vaccine. 2018 Mar 14; 36(12): 1700–1709.

    PATH, Pentavalent Vaccine in the Uniject™ Injection System: Health Care Waste Management Considerations. September 31 2014.

    Delivery cost analysis of a reactive mass cholera vaccination campaign: a case study of Shanchol™ vaccine use in Lake Chilwa, Malawi. Patrick G. Ilboudo and Jean-Bernard Le Gargasson. BMC Infect Dis. 2017; 17: 779. December 19 2017

    DTwP-HepB-Hib vaccine available in a compact, pre-filled auto-disable injection technology. UNICEF, Information Bulletin. March 2015

  2. Bulletin of the World Health Organization 2003, 81 (10), Paul K. Drain, Carib M. Nelson, & John S. Lloyd, Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries

  3. Divya Parmar, Elaine M Baruwa, Patrick Zuber & Souleymane Kone (2010) Impact of wastage on single and multi-dose vaccine vials: Implications for introducing pneumococcal vaccines in developing countries, Human Vaccines, 6:3, 270-278, DOI: 10.4161/hv.6.3.10397

  4. Vaccine. 2010 Jul 19; 28(32): 5292–5300.

  5. https://en.wikipedia.org/wiki/Glass_production

  6. U.S. Energy Information Administration, Glass manufacturing is an energy-intensive industry mainly fueled by natural gas, August 21, 2013

  7. https://www.weilerengineering.com/images/downloads/WhitePapers/Weiler-Catalent%20paper_FINAL.pdf

  8. Vaccine. 2010 Jul 19; 28(32): 5292–5300.

  9. https://www.fda.gov/downloads/drugs/guidances/ucm389069.pdf

  10. PATH, Reflections on Innovations in Global Health, The Radically Simple Uniject Device, January 2003, https://www.path.org/resources/the-radically-simple-uniject-device/

  11. Ibid

  12. BD Medical - Pharmaceutical Systems, BD Uniject™ Prefillable Injection System Technical Manual, Edition 4, June 2009

  13. See footnote 1

  14. Ibid

  15. Pharmaceutical Online, Blow/Fill/Seal Technology Automates Aseptic Vaccine Packaging, Andy Goll, Weiler Engineering, October 3, 2016

  16. Rommelag

  17. Rommelag Engineering https://rommelag-engineering.com/en/bfs

  18. International Pharmaceutical Quality, Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny, August 3rd, 2011

  19. PATH. Pentavalent Vaccine in the Uniject ™ Injection System: a Time and Motion Study. Seattle: PATH; 2014.

  20. Human Vaccines Journal, 01 Mar 2010, Volume 6, 2010 - Issue 3, Pages 270-278, Impact of Wastage on Single and Multi-dose Vaccine Vials: Implications for Introducing Pneumococcal Vaccines in Developing Countries, Divya Parmar, Elaine M. Baruwa, Patrick Zuber & Souleymane Kone

    Vaccine Wastage Assessment, UNICEF, April 2010, Field assessment and observations from National stores and five selected states of India

  21. Tiwari, Ranjana & Dwivedi, Shatkratu & Swami, Piyush & Mahore, Rakesh & Tiwari, Sakshi. (2017). A study to assess vaccine wastage in an immunization clinic of tertiary care centre, Gwalior, Madhya Pradesh, India. International Journal of Research in Medical Sciences. 5. 2472. 10.18203/2320-6012.ijrms20172431. https://www.researchgate.net/publication/317197954_A_study_to_assess_vaccine_wastage_in_an_immunization_clinic_of_tertiary_care_centre_Gwalior_Madhya_Pradesh_India, accessed 08/24/18.

    Vaccine. 2017 Dec 4;35(48 Pt B):6751-6758. doi: 10.1016/j.vaccine.2017.09.082. Epub 2017 Oct 21. https://www.ncbi.nlm.nih.gov/pubmed/29066189. Accessed 08/24/18.

  22. Bulletin of the World Health Organization 2003, 81 (10), Paul K. Drain, Carib M. Nelson, & John S. Lloyd, Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries

  23. See footnote 15

  24. See footnote 1

  25. Ibid

 

 

(Red Booklet)

When Injections Spread Disease

  1. The Burden of Unsafe Injections,” 2014 presentation by Benedetta Allegranzi, lead, Clean Care is Safer Care program, WHO Service Delivery and Safety HQ: http://www.who.int/medical_devices/Sun_pm_SAF_2_ALLEGRANZI.pdf, accessed 10-02-18.

  2. WHO Guideline on the use of safety-engineered syringes in health care settings; 2016, p. 7, www.who.int/infection-prevention/publications/is_guidelines/en/. Accessed 10-02-18.

  3. Bulletin of the World Health Organization 2003, 81 (10), Paul K. Drain, Carib M. Nelson, & John S. Lloyd, Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries. Accessed 10/15/2018.

  4. Report of WHO’s 2010 Safe Injection Global Network Meeting. www.who.int/injection_safety/toolbox/sign2010_meeting.pdf., Accessed 08/01/18.

  5. Second WHO Global Forum on Medical Devices, p. 133; Publication date: 2014. http://slideflix.net/doc/3517415/the-second-who-global-forum-on-medical-devices-report-pdf; accessed 10-02-18.

  6. Tiwari, Ranjana & Dwivedi, Shatkratu & Swami, Piyush & Mahore, Rakesh & Tiwari, Sakshi. (2017). A study to assess vaccine wastage in an immunization clinic of tertiary care centre, Gwalior, Madhya Pradesh, India. International Journal of Research in Medical Sciences. 5. 2472. 10.18203/2320-6012.ijrms20172431. https://www.researchgate.net/publication/317197954_A_study_to_assess_vaccine_wastage_in_an_immunization_clinic_of_tertiary_care_centre_Gwalior_Madhya_Pradesh_India, accessed 08/24/18. And: Vaccine. 2017 Dec 4;35 (48 Pt B):6751-6758. doi: 10.1016/j.vaccine.2017.09.082. Epub 2017 Oct 21., https://www.ncbi.nlm.nih.gov/pubmed/29066189. Accessed 08/24/18.

  7. Healthcare Without Avoidable Infections, WHO, 2016: p. 6. URL: apps.who.int/iris/bitstream/10665/246235/1/WHO-HIS-SDS-2016.10-eng.pdf. Accessed 10-02-18.

  8. www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm. Accessed 10/15/18.

  9. Perilous Infection-Conrol Practices with Needles, Syringes and Vials; Matthew Grissinger, RPh, FASCP; PT v.38(11); 2013 Nov; PMC3875254; www.ncbi.nlm.nih.gov/pmc/articles/PMC3875254; accessed 10-01-18

  10. http://www.who.int/mediacentre/news/releases/2015/injection-safety/en/. Accessed 10/15/18.

  11. The American Journal of Infection Control (2013, issue 41, p. 92-94).

  12. MMWR Morb Mortal Wkly Rep. 2012 May 18;61(19):339-43.

  13. Footage From 1976 Documents Discovery of Ebola Virus https://www.wsj.com/articles/footage-from-1976-documents-discovery-of-ebola-virus-1413470954. Dipti Kapadia and Gautam Naik, Oct. 16, 2014.

  14. Footage From 1976 Documents Discovery of Ebola Virus https://www.wsj.com/articles/footage-from-1976-documents-discovery-of-ebola-virus-1413470954. Dipti Kapadia and Gautam Naik, Oct. 16, 2014. And Pediatric Infect Dis J. 2015 Aug; 34(8): 893–897. doi: [10.1097/INF.0000000000000707]. Accessed 10/15/2018.

  15. Allegranzi, op cit., p. 30

  16. Allegranzi, op cit., p. 29

  17. Allegranzi, op cit., p. 33

  18. Allegranzi, op cit., p. 38

  19. https://nypost.com/2018/06/12/patients-being-tested-for-hiv-aer-nurse-reused-syringes/

  20. Dr. Benedetta Allegranzi, Coordinator, Infection Prevention and Global Control Unit – Service Delivery and Safety, WHO; “Health care without avoidable infections,” 2016.

 

(Red Booklet)

How We Manufacture a Prefilled Syringe with the World’s Lowest Cost Per Dose Delivered

All information on BFS manufacturing specifications can be found in Rommelag’s materials and on their website at https://www.rommelag.com/.

 

(Red Booklet)

Vaccine Technology: Its Past Evolution and Future Landscape

  1. Plotkin, Orenstein, Offit and Edwards, Plotkin’s Vaccines. 7th Edition, Elsevier June 6, 2017, p. 1320.

  2. Ibid.

  3. Plotkin, op cit; p. 1321.

  4. The Burden of Unsafe Injections,” 2014 presentation by Benedetta Allegranzi, lead, Clean Care is Safer Care program, WHO Service Delivery and Safety HQ: http://www.who.int/medical_devices/Sun_pm_SAF_2_ALLEGRANZI.pdf, accessed 10-02-18.

  5. Report of WHO’s 2010 Safe Injection Global Network Meeting. www.who.int/injection_safety/toolbox/sign2010_meeting. pdf. Accessed 08/01/18.

  6. http://www.who.int/mediacentre/news/releases/2015/injection-safety/en/. Accessed 10/15/18.

  7. Bulletin of the World Health Organization 2003, 81 (10), Paul K. Drain, Carib M. Nelson, & John S. Lloyd, Singledose versus multi-dose vaccine vials for immunization programmes in developing countries. Accessed 10/15/2018.

  8. Allegranzi, “e Burden of Unsafe Injections Worldwide,” https://www.who.int/medical_devices/Sun_pm_SAF_2_ALLEGRANZI.pdf, accessed 02/21/19.

  9. Dr. Francois Gasse, Unicef senior project manager for immunization and Mr. Masood Alam, Head of Commercial Operations, India Subcontinent, Chiron Vaccines, quoted on p. 11 of “The UnijectTM Device, a HealthTech Historical Profile,” June 2005.

  10. Plotkin, op cit., p. 1332.

  11. Plotkin, op cit., p. 1335.

  12. Plotkin, op cit., p. 1343-1346.

  13. Plotkin, op cit. p. 1345.

  14. Plotkin, op cit., p. 1336.

  15. Ibid.

  16. Plotkin, op cit., p. 1335.

  17. Ibid.

  18. Barolet and Benohanian, Clin Cosmet Investig Dermatol. 2018; 11: 231–238. Published online 2018 May 1. doi: 10.2147/CCID.S162724

  19. https://pharmajet.com/pharmajet-collaborates-worldhealth-organization/; and https://pharmajet.com/protecting-every-last-child-fractional-dose-polio-eradication/

  20. Ibid.

  21. Ibid.

  22. Ibid.

  23. Barolet and Benohanian, op cit.

  24. Plotkin, op cit., p. 1341.

  25. Ibid.

  26. PATH, “Microarray Patches for Drug Delivery,” Sept. 2016, https://www.path.org/resources/microarray-patches-fordrug-delivery/; accessed 02/21/19.

  27. Ibid.

  28. www.rh.gatech.edu/news/62737/nih-awards-10-milliondevelop-microneedle-vaccine-patch, accessed 01-25-19.

  29. www.eurekalert.org/pub_releases/2017-12/pndd113017.php, accessed 01-25-19.

  30. Plotkin, op cit., p. 1341.

  31. https://www.eurekalert.org/pub_releases/2017-12/pndd113017.php, accessed 02/21/19.

  32. http://edoriumjournals.com/blog/dissolvable-microarraypatch-pain-free-alternative-flu-injection; accessed 02/21/19.

  33. Ibid.

  34. Ibid.

  35. Giersing, et al, Vaccines, Volume 35, Issue 49, Part A, 14 December 2017, Pages 6793-6797; accessed 01-25-19.

  36. WHO report on Microarray Patch (MAP) Product Development Workshop Geneva, Switzerland, 8 December 2015; https://www.who.int/immunization/sage/meetings/2016/april/6_WHO_Microarray_Patch_final.pdf?ua=1; accessed 02/21/19.

  37. Van Norman, JACC (Journal of the American College of Cardiology): “Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices.” https://doi.org/10.1016/j.jacbts.2016.03.009. Accessed 01-25-19.

  38. Whitmore, Elaine, “Development of FDA-Regulated Products,” 2nd Edition, ASQ Quality Press, 2012, p. 120.

  39. Lloyd and Milstien, Bulletin of the World Health Organization 77(12):1001-7 б February 1999. www.who.int/bulletin/archives/77(12)1001.pdf

  40. Lloyd and Milstien, op cit.

  41. Ibid.

  42. For example, see “Drug Delivery Roundtable,” April 2011 issue of American Pharmaceutical Review - Volume 14, Issue 3. C; www.healthpolicyplus.com/IWD2017.cfm; and Swann, David (2013) Safer Disposable Syringe. GB 555666777.1. at http://eprints.hud.ac.uk/16087/, accessed 02-15-19.

  43. Allegranzi, ibid.

 

(Red Booklet)

Injectable Contraceptives Not Only Improve the Health and Lives of Women, but Transform Communities

  1. http://www.who.int/en/news-room/fact-sheets/detail/family-planning-contraception

  2. Ibid.

  3. Ibid.

  4. Ibid.

  5. Ibid.

  6. Ibid.

  7. https://www.unfpa.org/family-planning

  8. http://www.who.int/en/news-room/fact-sheets/detail/family-planning-contraception

  9. Ibid.

  10. Ibid.

  11. Ibid.

  12. Ibid.

  13. Ibid.

  14. Ibid.

  15. https://www.who.int/life-course/news/commentaries/lack-of-family-planning/en/

  16. https://www.gatesfoundation.org/What-We-Do/Global-Development/Family-Planning

  17. Ibid

  18. https://www.gatesfoundation.org/What-We-Do/Global-Development/Family-Planning

  19. https://www.businesswire.com/news/home/20170508005585/en/Collaboration-Helps-Broaden-Access-Pfizer%E2%80%99s-Contraceptive-Sayana%C2%AE

  20. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  21. https://www.who.int/en/news-room/fact-sheets/detail/family-planning-contraception

  22. https://www.gfmer.ch/Endo/Lectures_11/Arcangues.htm

  23. https://www.businesswire.com/news/home/20170508005585/en/Collaboration-Helps-Broaden-Access-Pfizer%E2%80%99s-Contraceptive-Sayana%C2%AE

  24. https://www.gfmer.ch/Endo/Lectures_11/Arcangues.htm

  25. Ibid.

  26. Ibid.

  27. Ibid.

  28. https://qz.com/239281/how-this-smart-contraceptive-design-could-liberate-women-in-africa/

  29. http://www.path.org/projects/uniject.php

  30. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  31. Ibid.

  32. Ibid.

  33. Ibid.

  34. PATH, Self-injected subcutaneous DMPA: A new frontier in advancing contraceptive access and use for women, August 2018

  35. World Health Organization, WHO Best Practices for Injections and Related Procedures Toolkit, March 2010

  36. World Health Organization. Family Planning/Contraception Fact Sheet. Available at: http://who.int/mediacentre/factsheets/fs351/en/. Accessed: February 22, 2017.

  37. https://qz.com/239281/how-this-smart-contraceptive-design-could-liberate-women-in-africa/

  38. https://www.businesswire.com/news/home/20170508005585/en/Collaboration-Helps-Broaden-Access-Pfizer%E2%80%99s-Contraceptive-Sayana%C2%AE

Also consult: http://www.un.org/en/development/desa/population/publications/pdf/family/trendsContraceptiveUse2015Report.pdf

 

(Red Booklet)

Pandemics - working title

Coming Soon.

 

(Red Booklet)

Pets/Small Farm Animals - working title

Coming Soon.

 

Blue Book

  1. http://www.who.int/mediacentre/news/releases/2015/injection-safety/en/. Accessed 12/3/18.

  2. http://www.who.int/immunization/rfp_review_missed_opportunities_vaccination/en/, accessed 12/3/18.

  3. Can a Compact Pre-Filled Auto-Disable Injection System (cPAD) Save Costs for DTP-HepB-Hib Vaccine as Compared with Single-Dose (SDV) and Multi-Dose Vials (MDV)? Evidence from Cambodia, Ghana, and Peru. Cyril Nogier, Patrick Hanlon, Karin Wiedenmayer, Nicolas Maire. January 29 2015.

    Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats. Jeff Sedita, Stefanie Perrell, Matt Morio, Michael Berbari, Jui-Shan Hsu,  Eugene Saxon, Courtney Jarrahian, Annie Rein-Weston, and Darin Zehrung. Vaccine. 2018 Mar 14; 36(12): 1700–1709.

    PATH, Pentavalent Vaccine in the Uniject™ Injection System: Health Care Waste Management Considerations. September 31 2014.

    Delivery cost analysis of a reactive mass cholera vaccination campaign: a case study of Shanchol™ vaccine use in Lake Chilwa, Malawi. Patrick G. Ilboudo and Jean-Bernard Le Gargasson. BMC Infect Dis. 2017; 17: 779. December 19 2017.

    DTwP-HepB-Hib vaccine available in a compact, pre-filled auto-disable injection technology. UNICEF, Information Bulletin. March 2015

  4. http://www.who.int/mediacentre/news/releases/2015/injection-safety/en/. Accessed 08/24/18.

  5. Ibid

  6. www.gavi.org/library/publications/gavi/gavi-2016-2020-mid-term-review-report/ Accessed 12/03/18.

  7. Ibid.

  8. PATH, Increasing access to lifesaving vaccines, Dec. 2013 PATH, A History of Vaccines, April 2015.

  9. The Journal of the American Osteopathic Association, May 2018, Vol. 118, 311-320. doi:10.7556/jaoa. 2018.062, Iatrogenic Hepatitis C Virus Transmission and Safe Injection Practices. AIDS Committee of North Bay & Area, Teresa Boyle, Experts Warn Against Use of Multi-Dose Vials http://aidsnorthbay.com/experts-warn-against-use-of-multi-dose-vials/.

  10. Royal College of Physicians of Edinburgh https://www.rcpe.ac.uk/heritage/college-history/alexander-wood British Journal of Hospital Medicine 2017 Nov 2;78 (11):647, Ellis, Harold, Alexander Wood: Inventor of the Hypodermic Syringe and Needle https://www.magonlinelibrary.com/doi/10.12968/hmed.2017.78.11.647.

  11. It’s a long, long walk: accessibility to hospitals, maternity and integrated health centers in Niger, Int J Health Geogr. 2012; 11: 24, 2012 Jun 27. doi: 10.1186/ 1476-072X-11-24, Justine I Blanford, Supriya Kumar, WeiLuo, and Alan M MacEachren. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3515413/.

  12. International Pharmaceutical Quality, Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny,Aug 3rd, 2011.

  13. Path Challenges and Innovations in Vaccine Delivery, 10th Annual African Vaccinology Course (AAVC): Developing Vaccinology  Expertise  for  Africa, 10–14 November 2014 Cape Town, South Africa, by Darin Zehrung, Senior Technical Officer and Portfolio Leader, Delivery Technologies, Vaccine and Pharmaceutical Technologies Group, 13 November 2014.

  14. Ibid. Pharmacy & Therapeutics, 2013 Nov; 38(11): 649, 666, Grissinger, Matthew,Perilous Infection-Control Practices With Needles, Syringes, and Vials. Bull World Health Organ. 1999; 77(10):789-800, Simonsen L., Kane A., Lloyd J., Zaffran M., Kane M., Unsafe Injections in the Developing World and Transmission of Bloodborne Pathogens: a Review.

  15. Ibid

  16. Ibid.

  17. Center for Disease Control and Prevention Health-care-Associated Hepatitis B and C Outbreaks (≥ 2 cases) Reported to the Centers for Disease Control and Prevention (CDC) 2008-2017 https://www.cdc.gov/hepatitis/outbreaks/healthcarehepoutbreaktable.htm.

  18. Footage From 1976 Documents Discovery of Ebola Virus https://www.wsj.com/articles/footage-from-1976-documents-discovery-of-ebola-virus-1413470954 Dipti Kapadia And Gautam Naik, Oct. 16, 2014.

  19. WHO, Universal health coverage and health financing http://www.who.int/health_financing/universal_cov-erage_definition/en/.

  20. WHO, Health systems/equity, http://www.who.int/healthsystems/topics/equity/en/.

  21. World Health Organization, Immunization Coverage Fact Sheet, 11 April 2018 http://www.who.int/en/news-room/fact-sheets/detail/immunization-coverage.

  22. Children’s Hospital of Philadelphia, Global Immunization: Worldwide Disease Incidence http://www.chop.edu/centers-programs/vaccine-education-center/global-immunization/diseases-and-vaccines-world-view.

  23. World Health Organization, Maternal Mortality Fact Sheet, 16 February 2018 http://www.who.int/en/news-room/fact-sheets/detail/maternal-mortality.

  24. www.gavi.org/progress-report/. Accessed 12-03-18.

  25. Bulletin of the World Health Organization 20 03, 81 (10), Paul K. Drain, Carib M. Nelson, & John S. Lloyd, Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries.

  26. Ibid.

  27. Ibid.

  28. http://www.who.int/immunization/rfp_review_missed_opportunities_vaccination/en/, accessed 08/24/18.

  29. Missed opportunities and barriers for vaccination: A descriptive analysis of private and public health facilities in four African countries, Comfort Zuyeali Olorunsaiye, Margaret Shaw Langhamer, Aaron Stuart Wallace, Margaret Lyons Watkins, Global Immunization Division, Centers for Disease Control and Prevention; Emory University.

  30. Human Vaccines Journal, 01 Mar 2010, Volume 6, 2010 – Issue 3, Pages 270-278, Impact of Wastage on Single and Multi-dose Vaccine Vials: Implications for Introducing Pneumococcal Vaccines in Developing Countries, Divya Parmar, Elaine M. Baruwa, Patrick Zuber & Souleymane Kone. Vaccine Wastage Assessment, UNICEF, April 2010, Field assessment and observations from National stores and five selected states of India.

  31. Path Challenges and Innovations in Vaccine Delivery, 10th Annual African Vaccinology Course (AAVC): Developing Vaccinology  Expertise  for  Africa, 10–14 November 2014 Cape Town, South Africa, by Darin Zehrung, Senior Technical Officer and Portfolio Leader, Delivery Technologies, Vaccine and Pharmaceutical Technologies Group, 13 November 2014.

  32. Ibid. And: Tiwari, Ranjana & Dwivedi, Shatkratu & Swami, Piyush & Mahore, Rakesh & Tiwari, Sakshi. (2017). A study to assess vaccine wastage in an immunization clinic of tertiary care centre, Gwalior, Madhya Pradesh, India. International Journal of Research in Medical Sciences. 5. 2472. 10.18203/2320-6012.ijrms20172431. https://www.researchgate.net/publication/317197954_A_study_to_assess_vaccine_wastage_in_an_immunization_clinic_of_tertiary_care_centre_Gwalior_Madhya_Pradesh_India, accessed 08/24/18. And: Vaccine. 2017 Dec 4;35(48 Pt B):6751-6758. doi:10.1016/j.vaccine.2017.09.082. Epub 2017 Oct 21. https://www.ncbi.nlm.nih.gov/pubmed/29066189. Accessed 08/24/18.

  33. See footnote 3.

  34. See footnote 3.

  35. The Lancet, 03 October 2015, Fiona Clark, Rise inOnline Pharmacies Sees Counterfeit Drugs Go Global https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00394-3/fulltext?code=lancet-site.

  36. International Pharmaceutical Quality, Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny, Aug. 3rd, 2011.

  37. Ibid.

  38. Immunization Action Coalition, Administering Vaccines, immunize.org/catg.d/p3085.pdf. Australian Diabetes Educators Association (ADEA), Clinical Guiding Principles for Subcutaneous Injection Technique, October 2015. www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-digital-version2.pdf.

  39. Information Packet #11: Recycling Is Business, by The Research Library for RCRA, U.S. EPA-New England, Spring 1995: p. 89V-2 (p. 6 of PDF). EPA Publication # 901R95005.

  40. U.S. Energy Information Administration, Glass manufacturing is an energy-intensive industry mainly fueled by natural gas, August 21, 2013 https://www.eia.gov/todayinenergy/detail.php?id=12631.

  41. Life Science Leader, Dan Schell, What You Should Know About Blow-Fill-Seal Technology, July 19, 2010 https://www.pharmaceutical online.com/doc/what-you-should-know-about-blow-fill-seal-0001.

  42. PATH, Reflections on Innovations in Global Health, The Radically Simple Uniject Device.

  43. Tiwari, Ranjana & Dwivedi, Shatkratu & Swami, Piyush & Mahore, Rakesh & Tiwari, Sakshi. (2017). A study to assess vaccine wastage in an immunization clinic of tertiary care centre, Gwalior, Madhya Pradesh, India. International Journal of Research in Medical Sciences. 5. 2472. 10.18203/2320-6012.ijrms20172431. Accessed 08/24/18. Vaccine. 2017 Dec 4;35(48 Pt B):6751-6758. doi:10.1016/j.vaccine.2017.09.082. Epub 2017 Oct 21. https://www.ncbi.nlm.nih.gov/pubmed/29066189 Accessed 08/24/18.

  44. https://www.gavi.org/library/news/roi/2010/gavi-catalyses-new-injection-safety-standards/

  45. Insider industry knowledge.

  46. Insider industry knowledge.

  47. PATH, Reflections on Innovations in Global Health, The Radically Simple Uniject Device.

  48. https://www.unicef.org/immunization/23245_safety.html

  49. Insider industry knowledge.

  50. BD Medical – Pharmaceutical Systems, BD Uniject™ Prefillable Injection System Technical Manual, Edition 4, June 2009.

  51. See footnote 3.

  52. See footnote 3.

  53. Rommelag Engineering https://www.rommelag-engi-neering.com/en/info/asepti c-filling/.

  54. Rommelag Engineering https://www.rommelag-engi-neering.com/en/bfs/.

  55. See footnote 3.

  56. See footnote 3.

  57. Estimate updated from World Health Organization, 2011. World Health Statistics 2011 - Table 6: Healthworkforce, infrastructure and essential medicines.

  58. https://www.independent.co.uk/life-style/health-and-families/health-news/worldwide-20-per-cent-of-children- go-unvaccinated-8581495.html – Accessed 08/20/18.

  59. WHO global database on maternal health indicators, 2017 update: http://www.who.int/gho/maternal_ health/en/ World Health Statistics 2017report, page 29.

  60. Dr. Henry Perry, senior scientist, Johns Hopkins Bloomberg School of Public Health, quoted p. 20 of One Million Community Health Workers Campaign’s Annual Report 2014: Building Healthy Communities by Bringing CHWs to Scale (Published on Mar 12, 2015). https://issuu.com/1millionhealthworkers/docs/annualreport2014.

  61. Immunization Action Coalition, Administering Vaccines, immunize.org/catg.d/p3085.pdf. Australian Diabetes Educators Association (ADEA), Clinical Guiding Principles for Subcutaneous Injection Technique, October 2015. www.adea.com.au/wpcontent/uploads/2015/11/Injection-Technique-Final-digital-version2.pdf.

  62. Blank

  63. WHO, Bulletin of the World Health Organization 2011;89:221-226. doi:10.2471/BLT.10.079426, 05 Jan. 2011, Intradermal delivery of vaccines: potential benefits and current challenges, JK Hickling, KR Jones, M Friede, D Zehrung, D Chen, D Kristensen, http://www.who.int/bulletin/volumes/89/3/10-079426/en/.

  64. The Lancet, 03 October 2015, Fiona Clark, Rise in Online Pharmacies Sees Counterfeit Drugs Go Global. PwC, Fighting counterfeit pharmaceuticals: New defenses for an underestimated - and growing - menace, Peter Behner, Dr. Marie-Lyn Hecht, Dr. Fabian Wahl, June 29, 2017 https://www.strategyand.pwc.com/reports/counterfeit-pharmaceuticals InSight Crime, Counterfeit Drugs Kill 1 Mn People Annually: Interpol, Natalie Southwick, Oct. 24, 2013 https://www.insightcrime.org/ news/brief/counterfeit-drugs-kill-1-million-annually-interpol/.

  65. Life Science Leader, Dan Schell, What You Should Know About Blow-Fill-Seal Technology, July 19, 2010.

  66. Interview.

  67. World Health Organization, WHO Best Practices for Injections and Related Procedures Toolkit, March 2010.

  68. U.S. Energy Information Administration, Glass manufacturing is an energy-intensive industry mainly fueled by natural gas, August 21, 2013.

  69. See footnote 3.

  70. See footnote 3.

  71. World Health Organization, Immunization Coverage Fact Sheet, 11 April 2018 http://www.who.int/en/news-room/fact-sheets/detail/immunization-coverage.

  72. Immunization Action Coalition, Administering Vaccines, immunize.org/catg.d/p3085.pdf. Australian Diabetes Educators Association (ADEA), Clinical Guiding Principles for Subcutaneous Injection Technique, October 2015 https://www.adea.com.au/wp-content/ uploads/2015/11/Injection-Technique-Final-digital-version2.pdf.

  73. The Lancet, 03 October 2015, Fiona Clark, Rise in Online Pharmacies Sees Counterfeit Drugs Go Global. PwC, Fighting counterfeit pharmaceuticals: New defenses for an underestimated - and growing - menace, Peter Behner, Dr. Marie-Lyn Hecht, Dr. Fabian Wahl, June 29, 2017.

  74. Life Science Leader, Dan Schell, What You Should Know About Blow-Fill-Seal Technology, July 19, 2010.

  75. U.S. Energy Information Administration, Glass manufacturing is an energy-intensive industry mainly fueled by natural gas, August 21, 2013.

  76. Information Packet #11: Recycling Is Business, by The Research Library for RCRA, U.S. EPA New England, Spring 1995: p. 89V-2 (p. 6 of PDF). EPA Publication # 901R95005.

  77. Pharmaceutical Online, Blow/Fill/Seal Technology Automates Aseptic Vaccine Packaging, Andy Goll,Weiler Engineering, October 3, 2016

  78. Rommelag Engineering https://www.rommelag-engineering.com/en/bfs/

  79. See footnote 3.

  80. UN News, New UN report finds bulk of world’s rural populations excluded from healthcare access, 27 April 2015 International Labor Organization, Global Evidence on Inequities in Rural Health Protection. New Data on Rural Deficits in Health Coverage for 174 Countries., Scheil-Adlung, X, 2015.

  81. World Health Organization, Maternal Mortality Fact Sheet, 16 February 2018.

  82. Life Science Leader, Dan Schell, What You Should Know About Blow-Fill-Seal Technology, July 19, 2010.

  83. Gavi, Inactivated Polio Vaccine Support, 22/03/2018.

  84. Centers for Disease Control and Prevention, National Early-Season Flu Vaccination Coverage, United States, November 2017, https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2017.htm. Vaccine, 2018 January 25; 36(4): 442–452, Pernille Jorgensen, Jolita Mereckiene, Suzanne Cotter, Kari Johansen, Svetla Tsolova, and Caroline Browna, How close are countries of the WHO European Region to achieving the goal of vaccinating 75% of key risk groups against influenza? Results from national surveys on seasonal influenza vaccination programmes, 2008/2009 to 2014/2015 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777640/.

  85. Natural, Resources Available Today and in the Future (book), Dahlquist and Hellstrand, editors, published by Springer, June 14, 2017, p. 4.

  86. Petsecure, A Guide to Worldwide Pet Ownership https://www.petsecure.com.au/pet-care/a-guide-to-worldwide-pet-ownership/.

  87. Insider industry knowledge.

  88. Internal calculation.

  89. TechRadar, What is NFC? Everything you need to know, Cameron Faulkner May 09, 2017 https://www.techradar.com/news/what-is-nfc.

  90. WHO, Effective Vaccine Management (EVM) Initiative. http://www.who.int/immunization/programmes_systems/supply_chain/evm/en/. WHO, UNICEF, Achieving immunization targets with the comprehensive effective vaccine management (EVM) framework, March 2016, http://www.who.int/immunization/programmes_systems/supply_ chain/ EVM-JS_final.pdf.

  91. https://www.statista.com/topics/2256/it-industry-in-india/.

  92. http://www.forbesindia.com/article/leaderboard/indian-it-services-sector-time-for-a-reboot/49671/1.

  93. https://www.statista.com/statistics/628210/mhealth-services-and-devices-market-size-in-india/.

  94. Ibid.

  95. https://economictimes.indiatimes.com/articleshow/52048195.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

  96. Open Key, The Evolution of Hotel Keys https://www.openkey.co/blog/the-evolution-of-hotel-keys. Hospitality Technology, Smart Guestroom Locks Becoming Standard, Dorothy Creamer, Managing Editor, 09/06/2013 https://hospitalitytech.com/smart-guestroom-locks-becoming-standard.

  97. TechRadar, What is NFC? Everything you need to know, Cameron Faulkner May 09, 2017.

  98. http://www.who.int/goe/publications/goe_mhealth_web.pdf.

  99. WHO –mHealth: new horizons for health through mobile technologies. Geneva, Switzerland: 2011.

  100. https://www.bmj.com/content/352/bmj.i1174.

  101. Ibid.

  102. https://thehonestanalytics.com/the-mhealth-mobile-healthcare-ecosystem-opportunities-growing-trends-and-demands-analysis-forecast-2018-to-2025/.

  103. http://www.who.int/goe/publications/goe_mhealth_web.pdf.

  104. Walker Table Systems http://www.wdtablesystems.com/pjm-technology/

  105. https://www.pharmaceuticalonline.com/doc/what-you-should-know-about-blow-fill-seal-0001

  106. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf

  107. http://www.worldpharmatoday.com/Articles/bfs-technology-for-parenteral-packaging

  108. https://www.pharmaceuticalonline.com/doc/what-you-should-know-about-blow-fill-seal-0001

  109. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf

  110. http://www.todaysmedicaldevelopments.com/article/tmd-0511-blow-fill-seal/

  111. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf

  112. http://www.todaysmedicaldevelopments.com/article/tmd-0511-blow-fill-seal/

  113. Ibid

  114. http://www.worldpharmatoday.com/Articles/bfs-technology-for-parenteral-packaging

  115. http://www.todaysmedicaldevelopments.com/article/tmd-0511-blow-fill-seal/

  116. http://www.todaysmedicaldevelopments.com/article/tmd-0511-blow-fill-seal/

  117. Rommelag

  118. http://www.todaysmedicaldevelopments.com/article/tmd-0511-blow-fill-seal/

  119. https://www.huffingtonpost.com/gil-laroya/modular-design-for techno_b_5008239.html

  120. https://www.weilerengineering.com/images/downloads/WhitePapers/Weiler-Catalent%20paper_FINAL.pdf

  121. https://www.rommelag-engineering.com/en/bfs/https://www.pharmaceuticalonline.com/doc/what-you-should-know-about-blow-fill-seal-0001

  122. http://www.who.int/immunization/programmes_systems/supply_chain/optimize/resources/en/index1.html

  123. www.psmarketresearch.com/market-analysis/prefilled-syringes-market, accessed 1-8-19.

  124. www.pharmtech.com/closer-look-prefilled-syringes,accessed 1-8-19.

  125. www.psmarketresearch.com/market-analysis/prefilled-syringes-market

  126. Pagay SN, Bachorik RJ, II, Richard TL. Pre-filled syringe and prefilled cartridge having actuating cylinder/plunger rod combination for reducing syringing force. Patent Storm: US Patent 5411489-Pre-filled syringe and pre-filled cartridge. 1995

  127. Beele Denise. Increasing Popularity of Prefilled Syringes. Packazine. 2007;1:4–5. And: Michael NE. The American Pharmaceutical Review. Cedar cottage, Newtimber Place Lane, West Sussex, BN6 9BU, United Kingdom: ON drug delivery Ltd; 2008. Offering a new choice in glass prefillable syringes; pp. 8–12.

  128. Int J Pharm Investig. 2011 Oct-Dec; 1(4): 200–206.doi: 10.4103/2230-973X.93004: 10.4103/2230-973X.93004

  129. Ibid.

  130. Nephron Pharmaceutical Corp.

  131. www.psmarketresearch.com/market-analysis/prefilled-syringes-market

  132. Challenges and Innovations with Prefilled Syringes, Sep 02, 2011, by Raul Soikes, BioPharm International, Volume 2011 Supplement, Issue 6.

  133. Ibid.

 



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