Safe Use of Pharmacy Isolator | Esco Pharma

Pharmaceutical compounding is a branch of pharmacy that continues to play a crucial role in drug development. Pharmacists develop and test pharmaceutical formulations for new drugs to ensure that active ingredients are effective and stable.
Physicians may prescribe individually compounded medications for patients with unusual health needs. Compounded preparations are especially common for:
- Patients requiring limited dosage strengths
- Patients with drug allergies
- Home healthcare and;
- Anti-cancer treatment.
Risks Involving Cytotoxic Drug Preparation:
Cytotoxic drugs sometimes known as antineoplastic anti-cancer or chemotherapy drugs include a wide range of chemical compounds because of their ability to kill tumor cells they're extensively used to treat cancer. However, their actions are not specific to tumor cells and normal cells may also be damaged as a result they can produce significant side effects in patients or others exposed this together with the increasing use and complexity of chemotherapy has raised concerns about the risks to health care workers involved in preparing and administering cytotoxic drugs.
Increases in health and safety requirements have led to greater use of Isolators to protect both patients and healthcare workers.
USP Guidelines and Requirements:
The United States Pharmacopeia the USP and other related organizations have established enforceable guidelines for sterile drug preparation an example of such guidance is USP chapter 797 which requires the use of engineering controls such as Isolators while conventional engineering controls such as laminar flow clean ventures and biological safety cabinets may be used USP 797 imposes stricter requirements on the environment in which this equipment must be cited. In Isolators, the total physical separation between the product and the pharmacy environment makes them more robust and immune to environmental disturbances.
Types of Isolators:
Isolators protect compounded drug products from room contaminants some offer operator and environmental protection for handling hazardous drugs three different types of Isolators are offered by manufacturers each designed for different applications:
1. Positive pressure Isolators are suitable for:
- Work involving non-hazardous materials.
- The work zone pass & through interchange are under positive pressure to the room;
- In order to maintain sterility in case of a breach in the barrier isolation system.
2. Negative pressure recirculating Isolators are suitable for:
- Work involving hazardous materials antineoplastic or cytotoxic compounding applications such as chemotherapy.
- The work zone and passed through interchange are under negative pressure to the room;
- In order to maintain operator protection in case of a breach in the barrier isolation system.
- They may be optionally vented.
3. Negative pressure total exhaust Isolators are suitable for:
- Work involving hazardous materials that may volatilize.
- The work zone and pass-through interchange are under negative pressure to the room;
- In order to maintain operator protection in case of a breach in the barrier isolation system.
- They must be externally vented.
How Isolators Work:
Isolators protect the product and in some cases the operator through the following:
Total physical separation between the product and the environment unlike in laminar flow clean benches or biological safety cabinets the operator works through ports in the front of the isolator the intentional use of air pressure relationships positive or negative defines the direction of airflow in and out of the isolator.
Watch the full video to learn how Isolators work, the safe use of Pharmacy Isolators, and the cleaning procedure and maintenance.
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[@vigneshkannan7422]

After USP 797 2023 was put into effect, the room requirements for the isolator where it was located were modified, so the video had to be updated.

[@luliuchen9826]

Thank you 🙏

[@EscoLifesciencesGroup]

You’re welcome 😊

[@yasmeenejaz5199]

Thanks

[@shamailabashir6209]

what would happen if there is a leak in the isolator or gloves

[@EscoLifesciencesGroup]

The response of an isolator during leakage depends on it's pressure configuration and breach mechanism. Leakage in the isolator or gloves may result to possible entry of air from the outside environment or release of air from the isolator.
We recommend at least semi-annual preventive maintenance and annual recertification of isolators to make sure that the unit is at it's top condition.

[@pankajkhedle5897]

Sterility

[@harihariharan401]

Oiv by BBB review