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Containment Options for the Freeze-Drying of Biological Entities and Potent Materials

  • Chris CherryEmail author
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

This chapter examines the characteristics and use of containment systems to perform various applications of freeze-drying. Specific consideration is given to containment system design, effects on mass and heat transfer, containment of microorganisms, and recommendations for the future application of containment options.

An assessment is made of previously characterized containment systems developed for freeze-drying which include a reusable aluminum box and the disposable Gore Lyoguard. Common design features of both were determined and a suitable, cost-effective, off the shelf alternative identified in the form of sterilization pouches. Further consideration is given to previous studies that have characterized and compared the effects on mass and heat transfer that barriers cause by increasing resistance to water vapor movement. In addition, the subsequent increases to heat transfer brought about by resistance to mass transfer are also further considered.

Key words

Containment Lyophilization Sterile processing Contamination Culture Disposables 

References

  1. 1.
    Wang W (2000) Lyophilisation and development of solid protein pharmaceuticals. Int J Pharm 203:1–60CrossRefGoogle Scholar
  2. 2.
    Trappler E (1995) Lyophilisation. In: Groves MJ, Murty R (eds) Aseptic pharmaceutical manufacturing II applications for the 1990s. Interpharm Press Incorporated, Buffalo Grove, ILGoogle Scholar
  3. 3.
    Snowman JW (1995) Lyophilisation under barrier technology. In: Groves MJ, Murty R (eds) Aseptic pharmaceutical manufacturing II applications for the 1990s. Interpharm Press Incorporated, Buffalo Grove, ILGoogle Scholar
  4. 4.
    Akers MJ (2010) Freeze-dry (lyophilisation) processing. In: Sterile drug products formulation, packaging, manufacturing and quality. Informa Healthcare, New York, NYGoogle Scholar
  5. 5.
    Suzuki O, Tanaka K, Watanabe N, Takeda M (2003) Design criteria and containment evaluation for pharmaceutical containment systems in aseptic dosage form manufacturing facilities. Pharm Technol 27:24–31Google Scholar
  6. 6.
    Taylor R, Boardman CFB, Wallis RG (1978) Sterile freeze-drying in an unclean environment. J Appl Chem Biotechnol 28:213–216Google Scholar
  7. 7.
    Gassler M, Rey L (2004) Development of a new concept for bulk freeze-drying: lyoguard freeze-dry packaging. In: Rey L, May JC (eds) Freeze-drying/lyophilization of pharmaceutical and biological products. 2nd edition, Informa Healthcare, New York, NYGoogle Scholar
  8. 8.
    Dunkelberg H, Rohmann S (2006) Test to determine sterile integrity of wrapped medical products at a probability of recontamination of 1:1,000,000. Infect Control Hosp Epidemiol 27(4):367–371CrossRefGoogle Scholar
  9. 9.
    Nolan PJ (2004) Sterile medical device package development. In: Standard handbook of biomedical engineering and design. McGraw-Hill, New York, NYGoogle Scholar
  10. 10.
    Dunkelberg H, Schmelz U (2009) Determination of the efficacy of sterile barrier systems against microbial challenges during transport and storage. Infect Control Hosp Epidemiol 30(2):179–183CrossRefGoogle Scholar
  11. 11.
    DuPont (2009) DuPont medical packaging guide technical reference guideGoogle Scholar
  12. 12.
    Pikal MJ (1985) Use of laboratory data in freeze-drying process design: heat and mass transfer coefficients and the computer simulation of freeze-drying. J Parenter Sci Technol 39:115–138PubMedGoogle Scholar
  13. 13.
    Cherry CLA, Millward H, Cooper R, Landon J (2014) A novel approach to sterile pharmaceutical freeze-drying. Pharm Dev Technol 19(1):73–81CrossRefGoogle Scholar
  14. 14.
    Konstantinidis AK, Kuu W, Otten L, Nail SL, Sever RR (2011) Controlled nucleation in freeze-drying: effects on pore size in the dried product layer, mass transfer resistance, and primary drying rate. J Pharm Sci 100(8):3453–3470CrossRefGoogle Scholar
  15. 15.
    Kuu WY, Hardwick LM, Akers MJ (2006) Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int J Pharm 313:99–113CrossRefGoogle Scholar
  16. 16.
    Tang X, Nail SL, Pikal MJ (2006) Evaluation of manometric temperature measurement, a process analytical tool for freeze-drying: Part II measurement of dry layer resistance. AAPS PharmSciTech 7(4):E77CrossRefGoogle Scholar
  17. 17.
    Lu X, Pikal MJ (2004) Freeze-drying of mannitol-trehalose-sodium chloride based formulations: the impact of annealing on dry layer resistance to mass transfer and cake structure. Pharm Dev Technol 9(1):85–95CrossRefGoogle Scholar
  18. 18.
    Patel SM, Pikal MJ (2010) Freeze-drying in novel container systems: characterisation of heat and mass transfer in glass syringes. J Pharm Sci 99(7):3188–3204CrossRefGoogle Scholar
  19. 19.
    Adams GDJ (1991) The loss of substrate from a vial during freeze-drying using Escherichia coli as a trace organism. J Chem Technol Biotechnol 52:511–518CrossRefGoogle Scholar
  20. 20.
    Adams GDJ (1994) Freeze-drying of biohazardous products. In: Hambleton P, Melling J, Salusbury T (eds) Biosafety in industrial biotechnology. Chapman and Hall, LondonGoogle Scholar
  21. 21.
    Stein CD, Rogers H (1950) Recovery of viable microorganisms and viruses from vapors removed from frozen suspensions of biologic material during lyophilisation. Am J Vet Res 11:339–344PubMedGoogle Scholar
  22. 22.
    Reitman M, Moss ML, Bruce Harstad J, Alg RL, Gross NH (1954) Potential infectious hazards of laboratory techniques. J Bacteriol 65(5):541–544Google Scholar
  23. 23.
    Busby D (1959) Contamination of apparatus during freeze-drying. J Hyg (London) 57:403–406CrossRefGoogle Scholar
  24. 24.
    Barbaree JM, Sanchez A (1982) Cross contamination during lyophilisation. Cryobiology 19:443–447CrossRefGoogle Scholar
  25. 25.
    Cammack KA, Adams GDJ (1985) Formulation and storage. In: Spier RE, Griffiths JB (eds) Animal cell biotechnology, vol 2. Academic Press Inc. Ltd., LondonGoogle Scholar
  26. 26.
    Adams GDJ (1996) Lyophilisation of vaccines. In: Robinson A, Farrar G, Wiblin C (eds) Methods in molecular medicine: vaccine protocols. Humana Press Inc., Totowa, NJGoogle Scholar
  27. 27.
    Cherry CLA, Cooper R, Millward H, Landon J (2015) Proof of concept: containment systems that prevent freeze-dryer contamination when lyophilizing Escherichia coli (JM 109). Drying Technol 33(4):466–470CrossRefGoogle Scholar
  28. 28.
    Patel SM, Pikal MJ (2011) Emerging freeze-drying process development and scale-up issues. AAPS PharmSciTech 12(1):372CrossRefGoogle Scholar
  29. 29.
    Mayeresse Y, de Cupere V, Veillon R, Brendle J (2009) Considerations for transferring a bulk freeze-drying process from a glass container to a tray. Pharm Eng 29:36Google Scholar
  30. 30.
    Cherry CLA (2013) Development of novel containment systems for freeze-drying. Doctoral dissertation, Cardiff Metropolitan UniversityGoogle Scholar
  31. 31.
    Nakamura T, Inatomi T, Sekiyama E, Ang LPK, Yokoi N, Kinoshita S (2006) Novel clinical application of sterilised, freeze-dried amniotic membrane to treat patients with pterygium. Acta Ophthalmol Scand 84:401–405CrossRefGoogle Scholar
  32. 32.
    Libera RD, Barreto de Melo B, Lima A, Haapalainen EF, Cristovam P, Gomes JAP (2008) Assessment of the use of cryopreserved freeze-dried amniotic membrane (AM) for the reconstruction of ocular surface in rabbit model. Arq Bras Oftalmol 71(5):669–673CrossRefGoogle Scholar
  33. 33.
    Jackson DW, Grood ES, Wilcox P, Butler DL, Simon TM, Holden JP (1988) The effects of processing techniques on the mechanical properties of bone-anterior cruciate ligament-bone allografts. Am J Sports Med 16(2):101–105CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.PDR, Cardiff Met UniversityCardiffUK

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