Waste Disposal and Decontamination Following the Preparation and Administration of In Vivo Gene Therapy

An overview of the disposal of waste materials and the decontamination of non-disposable items following the preparation and administration of gene therapy products

PRAC-biohazard.svg

Establishing and adhering to waste disposal and decontamination processes following gene therapy preparation and administration are crucial in protecting personnel and the environment1

Disposal of Waste Materials

Institutions should limit contact between gene therapy waste products and environment/people1

To address this, procedures for timely disposal of waste products should be established1

All disposable materials that have come into contact with gene therapy products should be disposed of as biological/biohazardous waste1,3

waste1.svg

Waste Disposal Process

Here are recommended processes for disposing of different types of waste products

waste2.svg

Figure reproduced from Chart 5 in Vulto AG, et al. 20071. *These can also be placed in autoclave bags if appropriate; Inactivation should be conducted according to legal regulations.

Decontamination of Non-disposable Items

Disinfectants

Disinfectants that have proven virucidal activity should be used for decontamination1, which include oxidizing/sterilizing agents. The susceptibility of the gene therapy product to such disinfectants may depend on the type of viral vector4. Examples of oxidizing/sterilizing agents include:

0%
bleach2 (1000 ppm chlorine has also been recommended)1
0%
1-2% Virkon1
0%
hydrogen peroxide1

Non-disposable Materials

Non-disposable items used during preparation and administration should be cleaned with suitable disinfectant1

Patient laundry should be treated as infectious and sealed in laundry bags as per institutional policy1

Biosafety Cabinet (BSC)

To meet U.S. Pharmacopoeia Chapter 800 standards, BSCs should be decontaminated2:

At least once daily between products, and after spills

Use of a log book to document the decontamination process is recommended and should be kept in the same room as the BSC1

transport5.svg

Decontamination procedures may include the following steps1,2,5:

waste3.svg

References

  1. Vulto AG, et al. EJHP Pract 2007;13:29–39.
  2. Blind JE, et al. Am J Health Syst Pharm 2019;76:795–802.
  3. Armitstead JA, et al. Hosp Pharm 2001;36(1):56–66.
  4. Petrich J, et al. J Pharm Pract 2020:33(6):846–855.
  5. DeCederflet HJ, et al. Am J Health Syst Pharm 1997;54:1604–1610.