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Parametic release
Parametric release
| Question | Answer |
|---|---|
| What is parametric release? | The release of a batch of sterilised items based on process data rater than on the basis of submitting a sample of the items for sterility testing. It recognises that in process tests are giving assurance for product sterility than a sterility test itself |
| When can parametric release be used? | When a fully validated terminal sterilisation method by steam, dry heat or ionising radiation has been used and approval granted by a competent authority. |
| What is meant by process validation? | To validate the chosen sterilisation procedure before it is applied in practice to ensure its effectiveness and the integrity of the product. Not following a stringent validation process increases risk for non-sterile product. |
| Good manufacturing practice supports process validation. What are the princilpes of good manufacturing practice? | Qualified personnel with appropriate training Adequate premises Suitable equipment, easily cleaned and sterilised Adequate precautions to minimise bioburden before sterilisation validated procedures for all critical steps environment/in process tests |
| What is commisioning data? | Evidence that equipment has been installed in accordance with specifications, equipment is safe to use and equipment functions within predetermined limits |
| What is performance qualification data? | Evidence that equipment will produce a product with an acceptable assurance of sterility Physical performance qualification - specified sterilisation conditions have been met during sterilisation Biological PG: sterilising conditions met lethality stand |
| What is the validation of a sterilisation process? | Tests the processes in the sterilisation cycle to ensure they meet specified and established standards. Does not involve the testing of any products. Keeps variables of a sterilisation process within validated limits. In control = product meets sterility. |
| What are process indicators and what types are used for validation testing? | Process indicators provide information on where a sterilisation process can/may go wrong Types: sterilisation, biological and chemical |
| What are the physical indicators used in validation testing? | Temperature and time (key parameters) pressure variation gas concentration relative humidity (hygrometers) steam purity delivered dose (dosimeter) |
| How are chemical indicators used in validation process testing? | vary depending on sterilisation method, but chemical indicators change in physical or chemical nature in response to one or more parameters. Demonstrate that an indicator has been subjected to a process, no indication that sterilisation was satisfactory |
| List the chemical indicators used in validation testing? | Dry heat indicator,seal packs and indicator tapes, thermolog S integrator for moist heat,, thermalog Ethylene oxide Integrator, Bowir Dick test for air removal, Browne's tubes |
| Explain the dry heat indicator | Chemical indicator strip used to monitor exposure to time and temperature. Confirms that the sterilant has reached where the pack was placed and confirms heat conditions have been met. Changes colour when exposed to correct dry heat and temperature |
| Explain exposure monitoring with seal packs and indicator tapes | Designed to seal packs and act as visual evidence that the packs have been exposed to steam sterilisation. Tapes assure operator post sterilisation that packs have been exposed without pack opened or check control load records. |
| How does the Thermalog S Integrator for moist heat work? | Steam enters the permeable topside of the device, chemical melts and moves along the wick, distance and extent of movement depends on exposure to steam, time and temp. 2 windows SAFE/UNSAFE. Colour should be in safe window, if not, parameters not present. |
| How does the Thermalog ethylene oxide integrator work? | EO and moisture enter unsealed side of integrator, strips turns blue and moves along the wick. Extent depends on exposure to Eo conc'n, humidity, time and temp. 2 windows SAFE/UNSAFE, blue colour should in safe window, if not, parameters were not present. |
| Of the chemical indicators, which two give a better idea if sterilisation might have been achieved? | The thermalog EO integrator, and the Thermalog S Integrator |
| Explain the Bowie Dick test | Monitors the effective removal of air in autoclaves with a pre-vacuum cycle. It is autoclave tape inserted into the centre of a test pack of cotton towels following sterilisation. Colour change. Used on first cycle of day as equipment function test. |
| Explain Browne's Tubes | Glass tubes with red liquid that turns green after 60 minutes at 160C. Black spot tubes change colour after 20 minutes at 121C. Colour change indicates succesful sterilisation. More reliable marker of sterility, colour changes shows temp and time were met |
| How are biological indicators used in validation testing? | Standardised preparations of MO's used to assess effectiveness of a sterilisation procedure. Chosen MO is usually most resistant to a particular process. After exposure, incubated in media to detect any surviving MO's. No growth = sufficient lethality. |
| How are the biological indicators presented? | Spores in an inert carrier like a strip of filter paper or test pieces that resemble the load being tested like contaminated gauze or contaminated syringe. |
| How is a sterility test on a product different to validation testing? | Relies on statistical probability - not reliable: probability of detecting MO's via the sterility test increases as MO # increases. Varies based on MO readiness to grow. Low probability of detecting low levels of contamination. |
| How else is a sterility test different to a validation test? | Sterility testing is destructive, and the interpreation is based on the principle that if every container in the batch was tested, the result would be the same. Need goos sampling pass or fail principle - no knowing where things might have gone wrong |
| What are the conditions for parametric release to be used? | Only for terminally sterilised products in final container. sterilisation method of dry heat, steam, ionising radiation used. Successfully demonstrate using in-test data that predetermined, validated sterilising conditions have been met. |
Created by:
LDM
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