Usefulness of biosafety cabinets for the preparation of sterile topical and urological solutions

Sterile topical solutions are any that are performed under strict aseptic parameters and are usually marketed as rinses, aerosols, or drops. They usually have low viscosity and often contain water or alcohol as a base. Sterile compounding is defined as combining, mixing, diluting, repackaging, or modifying any other drug or bulk drug substance to create a sterile drug. There are various topical formulations in the form of solutions, creams, powders, foams and transdermal patches.

Principles of good practice for the development of magistral formulas

Compounding procedures should be designed and developed in accordance with the requirements of good manufacturing practice and quality control as outlined in the Pharmacopoeias and international guidelines. Principles of all procedures involved in compounding that are the responsibility of the pharmacist or pharmaceutical chemist. These include the minimum general requirements for personnel, facilities, equipment and materials, documentation, prescribing, compounding, quality control and dispensing. In order to minimize any harm to the health of patients that may be caused by:

  • Microbial contamination (non-sterility).
  • Excessive bacterial endotoxins.
  • Variability from the expected concentration of ingredients.
  • Physical and chemical incompatibilities.
  • Chemical and physical contaminants.
  • Use of ingredients of inappropriate quality.

Importance of biosafety cabinets for the preparation of sterile topical and urological solutions

Biosafety cabinets protect the user and the environment from the risks associated with the handling of infectious and other biohazardous materials. The design of the equipment provides features for the efficient treatment of exhaust air, variations in air intake velocity, percentage of recirculated air, etc., to prevent pollution during the preparation of sterile solutions.

Preparation environment for sterile topical solutions

The infrastructure and facilities must be properly designed, equipped and maintained to minimize the risk of pollution. To reduce exposure, preparations should be performed in laminar flow biosafety cabinets that provide a containment barrier, which offers an environment with ISO Class 5 or better air quality. This equipment has a unidirectional horizontal or vertical airflow with HEPA filtration. They are suitable for retaining aerosols that are generated during experimental procedures with biological agents such as agitation, centrifugation or mixing.

To achieve good results, good performance and efficiency of the final products, procedures for working safely should be followed, including:

  • Plan in detail the procedures to be followed.
  • Activate the biosafety cabin.
  • Load materials and equipment.
  • Perform procedures.
  • Download materials and equipment.
  • Clean and disinfect the biosafety cabinet at the end.
  • Turn off the biosafety cabinet at the end.

Types of biosafety racks

  • Biological safety class I: belongs to a group of equipment designed to improve the general conditions of activities carried out in clinical and research laboratories in the field of public health.
  • Biological safety class II: is characterized by the protection of the personnel, the environment and the product. These booths have two grids, one front and one back, and a HEPA filter system, through which the air circulating on the work surface is sucked, provides a vertical laminar flow that protects the product and avoids the possibility of cross-contamination.
  • Class III Biological Safety Cabin: it is designed to work with microbiological agents classified in biosafety levels 3 and 4. It is characterized by being totally closed. The placement of materials inside the cabin is done through a passage box. The injection and extraction of air in the cabin is used with a HEPA filter system.

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