What are the errors that might occur during preparing sterile products?
Results: In the preparation stage, the following errors were identified: no hand hygiene (70.29%), and no use of aseptic technique (80.85%). Upon administration, no hand hygiene (81.18%), and no use of aseptic technique (84.81%).
What are the USP 797 guidelines?
The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).
What are the general considerations in WHO good manufacturing practices for sterile pharmaceutical products?
General considerations 1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials.
Which of the following is a critical site of a sterile product?
Critical Sites: Syringes, Needles and Vials A critical site is any opening or surface that can provide a pathway between the sterile product and the environment. Examples include the tip of a needle, rubber stopper and ribs of the plunger on a syringe.
What should you do if you give someone the wrong medication?
If the patient tells you it is the wrong medication or treatment, stop and check the order. Check physician orders for changes, and if you are unsure of a dosage, ask another nurse or the pharmacist to double-check your calculations.
What do you do with an impossible prescription?
Impossible prescription shall not be filed. They shall be and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
What is the difference between USP 797 and USP 800?
The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
What is the difference between USP 795 and USP 797?
Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.
WHO GMP main principles for pharmaceutical products?
1.1 Principle. The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy.
What is the importance of following sterile wearing during sterile manufacture like mouth piece?
They protect the eyes and face from splashing and impact of objects. Their material will depend on the activity being carried out.
Which of the following is a critical site that must be disinfected during the sterile compounding process?
Except for the cap, all parts of the needle are considered critical sites. The protective overwrap must be disinfected with a product that does not leave a residue, such as sterile 70% IPA, before placing the needles into the work area.
What is shadowing contamination?
Contamination of the critical site of any supply item by interruption of the sterile airflow from the HEPA filter to the critical site; also known as shadow contamination. A container for sterile liquid or powdered medication.