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to aseptic processing. This draft guidance states that terminal sterilization
provides the highest assurance of sterility and should be used whenever
possible. It continues by stating that for highly sensitive products such as
biological products where terminal sterilization of the product is not pos-
sible, aseptic processing under controlled conditions provides a satisfactory
quality of the medicinal product and that the use of aseptic processing
can be accepted in certain situations even if the formulation itself can be
terminally sterilized if other benefits are gained for the patients or users of
the product.

9.6 Summary

There are standards and guidelines associated with providing sterile health-
care products that could provide optimal pathways for sterility assurance of
innovative new products for patients worldwide. It is the task of the manu-
facturer to investigate the options and possibilities before selecting a course
of action. Integral to that approval is the sterile label claim and mechanism
by which it is supported, because the final authority for approving a claim
of sterile resides with the regulatory authority of a particular country or
region. For manufacturers and regulators alike, the ultimate goal is patient
safety, therefore selecting the means of delivering sterile product requires
knowing the options, assessing the risks associated with each option, com-
plying with applicable regulations, and then determining the approach that
creates the best outcome for the patient, the product, and the company.

Further reading

[1] Directive 2001/83/EC of the European Parliament and of the Council of 6 November
2001 on the Community Code Relating to Medicinal Products for Human Use (OJ L
311, 28.11.2001, p. 67).
[2] Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices (OJ L 169,
12.7.1993, p. 1).
[3] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April
2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) no
178/2002 and Regulation (EC) no 1223/2009 and Repealing Council Directives
90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
[4] Regulation (EC) No 1394/2007 of the European Parliament and of the Council of
13 November 2007 on Advanced Therapy Medicinal Products and Amending Direc-
tive 2001/83/EC and Regulation (EC) no 726/2004 (OJ L 324, 10.12.2007, p. 121).
[5] Directive 2004/23/EC of the European Parliament and of the Council of 31 March
2004 on Setting Standards of Quality and Safety for the Donation, Procurement, Test-
ing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells
(OJ L 102, 7.4.2004, p. 48).