Why disinfectant sterilization required in pharma injectable?


Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores.

Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects and  reduces the pathogen load on Surfaces.

Disinfection is the method to destroy most microbial forms, especially vegetative pathogens rather than bacterial spores, by using physical and chemical procedures such as UV radiation, boiling, vapor. Each pharmaceutical and surgical process and medical applications need sterile procedures to avoid infection of tissue by surgical and medical equipment  and products by pharmaceutical equipment’s that are contaminated. During these processes, surgical and medical /pharmaceutical equipment can be contaminated by pathogens via contaminated surgical gloves. This leads to entrance of bacteria adhered on surgical and medical equipment or devices to sterile tissues of patient /pharmaceutical products as a result of infection or contaminated injectable products. Not only contaminated surgical and medical /pharmaceutical equipment are risk factors for infection or microbial contamination but also contaminated common areas used by community such as toilets, change rooms and door handles and contaminated air causing transmission of pathogens from person to person and contaminated kitchen equipment causing cross contamination between equipment and foods are risk factors for health-threatening infections.

Inadequate disinfections of these equipment and air are risk factors for transmission of pathogens to patients. Hepatitis B, hepatitis C, Rota virus, Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli , Salmonella typhimurium, Shigella dysenteriae, Vibrio cholera, and Helicobacter pylori are the most common examples of pathogens transmitted. Failure to apply disinfection applications has been leading to various outbreaks.

Contaminated biotic surfaces such as skin, contaminated abiotic surfaces such as medical devices, and kitchen equipment exposed to cross contamination must be disinfected to prevent pathogens. Alcohols, chlorine and chlorine compounds, quaternary ammonium compounds, phenolics, iodophors, formaldehyde, glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, peracetic acid are examples of disinfectants used. Microbicide metals, ultraviolet radiation (UV), pasteurization were also used for disinfection of surfaces, as miscellaneous inactivating agents

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Efficacy of disinfection

Bactericidal effects of disinfectants vary against each microorganism. According to efficacy of disinfectant, appropriate disinfectant must be used against each microorganism. For example, a few types of disinfectants are not suitable for cold, due to inefficacy of disinfectant at lower temperatures of environment. This problem can be overcome by selecting appropriate disinfectant of which effect is high in cold conditions.

Temperature and pH of the disinfection process, amount of microorganism, physical factors such as surface type, chemical factors such as chemical composition of surface or disinfectant, antibacterial resistance of microorganism, biofilm production of microorganism, dose of disinfection, and duration of exposure to disinfection are the factors affecting efficacy of disinfectant against pathogens

Factors that affect the efficacy of both disinfection and sterilization include prior cleaning of the object; organic and inorganic load present; type and level of microbial contamination; concentration of and exposure time to the germicide; physical nature of the object (e.g., crevices, hinges, and lumens); presence of biofilms; temperature and pH of the disinfection process; and in some cases, relative humidity of the sterilization process (e.g., ethylene oxide).

Unlike sterilization, disinfection is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3–12 hours); these are called chemical sterilants. At similar concentrations but with shorter exposure periods (e.g., 20 minutes for 2% glutaraldehyde), these same disinfectants will kill all microorganisms except large numbers of bacterial spores; they are called high-level disinfectantsLow-level disinfectants can kill most vegetative bacteria, some fungi, and some viruses in a practical period of time (≤10 minutes). Intermediate-level disinfectants might be cidal for mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores. Germicides differ markedly, primarily in their antimicrobial spectrum and rapidity of action.

Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Decontamination removes pathogenic microorganisms from objects so they are safe to handle, use, or discard.

Terms with the suffix cide or cidal for killing action also are commonly used. For example, a germicide is an agent that can kill microorganisms, particularly pathogenic organisms (“germs”). The term germicide includes both antiseptics and disinfectants.

Antiseptics are germicides applied to living tissue and skin but disinfectants are antimicrobials applied only to inanimate objects.


Typically, disinfectants used in aseptic filling areas are diluted with Water for Injection and are prepared aseptically

  • Purpose

To prevent introduction of foreign organisms into environment

  • Sterilization practices


0.22 micron

PVDF, Teflon (PTFE)

  • Gamma irradiated concentrates
  • WFI dilution required

Suspension test

Estimate the in vitro bactericidal activity of the disinfectant under precise experimental conditions including

  • Microbial strain
  • Preparation of inoculum
  • Volume of inoculum vs. disinfectant
  • Temperature
  • Disinfectant concentration and contact period
  • Interfering substances (i.e. inorganic, organic matter)

Suspension test

Estimate the in vitro bactericidal activity of the disinfectant under precise experimental conditions including Microbial strain

  • Preparation of inoculum
  • Volume of inoculum vs. disinfectant
  • Temperature
  • Disinfectant concentration and contact period
  • Interfering substances (i.e. inorganic, organic matter)

Carrier test

Estimate the in vitro bactericidal efficacy when reproducing surface disinfection conditions including

  • Substrate
  • Application technique
  • Spray, immersion or wipe
  • Drying time
  • Surface area vs. inoculum
  • Interfering substances
  • Issues

Recovery from surface

Surface condition




About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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