Contents
- 1 How often for media fill test?
- 2 How often is surface sampling required?
- 3 How do you perform a media fill test?
- 4 WHO Guidelines media fill?
- 5 How often is surface sampling of all classified area required?
- 6 How often are media fill tests of personnel required?
- 7 What are quality assurance procedures for medium risk CSPs?
How often for media fill test?
The incubation period of a media fill should be no less than 14 days and the containers should be examined every 2 or 3 days. All steps in a media fill should be done in the same locations as the drug production steps.
What is media fill test?
Media fill test is a process simulation testing which is carried out in the same manner as that of normal production except that an appropriate microbiological growth medium is used in place of the drug.
How often is surface sampling required?
every six months
Currently, viable surface and air testing are required every six months at a minimum. USP <797> laboratory testing services are an essential component of pharmaceutical environmental monitoring programs.
How often should training of compounding personnel be performed and documented?
All compounding personnel must be visually observed initially and every 6 months while performing hand hygiene and garbing procedures (see 3. Personal Hygiene and Garbing). The visual audit must be documented and the documentation maintained to provide a record of personnel competency.
How do you perform a media fill test?
The Media Fill Test Process
- Acquire testing medium.
- Choose the time and circumstances of the test.
- Carry out the test.
- Incubate the test sample.
- Assess the results.
- Follow up.
Is media fill required for terminally sterilized products?
How do we make sterile products ? Terminal sterilization – where the final filled product is sterilized (e.g. in an autoclave or by irradiation.) Media Fill is not required.
WHO Guidelines media fill?
For small batches the number of containers for media fills should at least equal the size of the product batch. The target should be zero growth and the following should apply: when filling fewer than 5000 units, no contaminated units should be detected.
What kind of media must be used for surface sampling?
What type of media should be used to perform surface sampling? Surface Sampling is performed using general growth media (e.g., tryptic soy agar) to which neutralizing agents such as lecithin and polysorbate 80 have been added. These chemicals neutralize the effects of cleaning agents to help prevent false negatives.
How often is surface sampling of all classified area required?
Settling plates that were once suggested in earlier National Formulary guidelines are not permitted in the 2008 USP 797 revision since all sampling must now be volumetric. Surface sampling is required in all ISO classified areas on a periodic basis.
How long do vertical or horizontal flow hoods need to run before performing any IV preparations?
2) Whichever laminar flow hood design you choose, be sure to run it for at least 15 minutes before you begin critical operation, to allow particles to be purged from the enclosure. 3) Remember the sweeping direction, from clean to dirty, whenever you clean a hood.
How often are media fill tests of personnel required?
turbidity, which indicates the presence of microbial contaminants. How often are media-fill tests of personnel required? Minimally, USP Chapter <797> requires media fill validation initially upon hire, then annually for low- and medium-risk compounding, and twice annually for high-risk compounding.
How long can you store a medium risk CSP?
Generally, medium-risk CSPs do not have broad-spectrum bacteriostatic substances and are administered over multiple days. Without passing a sterility test, medium-risk CSPs may be stored for 30 hours at room temperatures of 25 to 40 degrees Fahrenheit, 9 days at cold temperatures and 45 days if frozen solid and held at -20 degrees or less.
What are quality assurance procedures for medium risk CSPs?
Quality Assurance—Quality assurance procedures for medium-risk level CSPs include all those for low-risk level CSPs, as well as a more challenging media-fill test passed annually, or more frequently.
How often do you need media fill validation?
Minimally, USP Chapter <797> requires media fill validation initially upon hire, then annually for low- and medium-risk compounding, and twice annually for high-risk compounding.