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Mini-Bio-Plus self-contained biological indicators (SCBI)

Application

The gke Steri-Record® Mini-Bio-Plus self-contained biological indicators (SCBI) are used for validation and routine monitoring of steam, ethylene oxide, formaldehyde and hydrogen peroxide/plasma sterilization processes. After sterilization the SCBIs can be incubated by the user without a microbiological laboratory.The newly developed Instant-Mini-Bio-Plus SCBI allows an immediate release of the load in steam sterilization processes without having to wait for the result after incubation. The Mini-Bio-Plus SCBIs can be used for routine monitoring inside packs or containers. They have also been designed to be used inside a gke Steri-Record Bio-Compact Process Challenge Device (Bio-CPCD). Special adaptations have been made to the SCBI so it can be used together with a PCD as a class 2 indicator according to EN ISO 11140-1 which reaches the required sensitivity to check the internal lumens of a minimal invasive surgical (MIS) instrument.

Five Bio-C-PCDs with different air removal characteristics are available. The sensitivity of these Bio-CPCD s can be selected to meet the requirement of the load. The validation of the Bio-C-PCDaccording to the load can be achieved by using the test method described in DIN 58921.gke Bio-C-PCDs can be used in all four sterilization processes mentioned above, if the correct SCBI is inserted. There are various hydrogen peroxide/plasma sterilization processes in the market with different penetration characteristics of the sterilization agent. Depending on the process used and on the load configuration an appropriate Bio-C-PCDshould be selected.

Product Description

The gke Steri-Record® Mini-Bio-Plus SCBI uses a plastic vial with a minimized internal volume containing a biological indicator spore disc and a glass ampoule with a growth medium and pH-indicator inside. For steam, ethylene oxide* and formaldehyde sterilization processes, filter paper is used as a carrier and as a closing filter below the cap. For hydrogen peroxide/plasma sterilization processes plastic material is used. For a better recognition of the different SCBI versions they each have different coloured caps (see table).

The outside label of the SCBI contains a class 1 chemical indicator according to EN ISO 11140-1 to check, if the SCBI has been in a sterilization process. Additionally the Instant-Mini-Bio-Plus SCBI also contains a class 5 chemical indicator inside the SCBI allowing the result of steam sterilization processes to be instantly evaluated at the end of the process. Therefore, it is not necessary to wait for the outcome of the SCBI incubation since the class 5 indicator provides equivalent or better information about the result of the sterilization process according to the above chemical indicator standard. The specially designed and patented gke Steri-Record® Bio-C-PCDconstruction consists of a large initial internal volume with a stainless steel tube inside and a minimal capsule volume at the closed end. It can be used only with the specially designed MiniBio-Plus SCBIs as described before, to create a high sensitive Hollow Load PCD. Conventional SCBIs cannot be used because of the lower sensitivity for air removal and steam penetration inside the PCD. For incubation of all SCBIs gke Steri-Record®incubators with two different temperatures and programming versions are available (see separate data sheet).

Performance Characteristics

Self-contained biological indicators: All gke biological indicators comply with the standard EN ISO 11138 series and meet the performance characteristics published in the current United States Pharamcopeia (USP) and European Pharmacopeia (EP). For hydrogen peroxide sterilization processes the standard EN ISO 11138-6 draft is currently under development and not yet available. gke Mini-Bio-Plus SCBIs for hydrogen peroxide sterilization processes are supplied with a D-Value that is tested under the defined sterilization conditions described in the certificate. The SCBIs for Low Temperature Steam Formaldehyde (LTSF) sterilization processes contain in the growth medium substances, decomposing remaining absorbed formaldehyde, so that the pretreatment with Na2SO3 according to EN ISO 11138-5 is not required anymore and the results can be obtained much faster.The incubation time of all Mini-Bio-Plus SCBIs has been optimized, so that steam and H2O2-Mini-Bio-Plus SCBIs can be fully interpreted within 24 hours and ethylene oxide and formaldehyde Mini-Bio-Plus SCBIs within 48 hours incubation time. The SCBIs do not contain additional enzymes and do not require fluorescent light for evaluation and therefore, standard incubation can be used. If the incubation time exceeds the recommended time, the colour of the media does not change back, as some conventional SCBI media do. If the sterilization process is unable to kill the spores, in most cases the colour change will already occur within 5-8 hours.While Steam-Mini-Bio-Plus SCBIs may be used for all steam sterilization processes of 121-137°C, InstantSCBIs shall be used for processes of 132-137°C only and contain a class 5 indicator according to EN ISO 11140-1. The indicator enables the user to interpret the result immediately at the end of the process. The result of a class 5 indicator provides a much higher probability of sterility compared to the result of a SCBI incubation after 3 hours where the probability of < 99 % is achieved after this minimal incubation time only.

Special test systems using Bio-C-PCDs and SCBIs inside:

Bio-C-PCD s with gke SCBIs inside can simulate porous loads and hollow devices simultaneously. A special Bio-C-PCDto simulate the hollow load device described in EN 867-5 is available as well. Additional Bio-C-PCDs are available to simulate different load configurations and may be validated according to the test method, described in DIN 58921.

Operational Description

The SCBI must be placed inside the most difficult penetration condition of packs or containers but in hollow devices like MIS instruments they cannot be placed inside. In this case a Bio-C-PCD with a SCBI inside is used to simulate MIS instruments. This alternative offers for the first time the possibility to check sterility inside hollow instruments. SCBIs in PCDs can be directly incubated at the end of the cycle without having to open packs or containers.After the sterilization process the SCBIs are taken out of the load or the Bio-C-PCD and are activated by crushing the glass ampoule. After they are incubated correctly according to the directions for use, the colour of the liquid will indicate a pass or fail of the sterilization process. If the colour has not changed, this indicates a pass of the process, a colour change indicates a fail.Temperature stability of all SCBI is up to 145°C and can be used in all steam and low temperature sterilization processes but should not be used in dry heat sterilization processes at all.

Benefits

  •  First worldwide PCD-system (class 2 indicator) with a special internal volume design hosting the gke Steri-Record® SCBI which simulate hollow devices.
  •  Immediate release at the end of the steam sterilization process by checking the colour change of the class 5 chemical indicator. without waiting 3 hours for incubation with an increased probability of the result at the end of the process. In addition the proof of the biological indicator result will be available after incubation.
  •  Cost reduction using SCBIs with direct incubation by the user instead of using a microbiological laboratory.
  •  Special Mini-Bio-Plus SCBI design with minimized internal volume usable in Bio-C-PCD s for steam, ethylene oxide, formaldehyde and hydrogen peroxide/plasma sterilization processes.
  •  Mini-Bio-Plus SCBIs can be incubated on completion of each cycle without having to open any packs or containers when used in Bio-C-PCDs.
  •  Simple handling and traceability of test results els on the SCBI are self-adhesive and can be removed for external documentation.
  •  The combination of Mini-Bio-Plus SCBI and specially designed Bio-C-PCD s allows correct testing of hollow lumen instruments.
  •  Several Bio-C-PCDs are available to simulate different loads.
  •  A special oval and round Bio-C-PCD design for use in small table-top or large sterilizers.
  •  Cost-effective due to multiple use of the Bio-C-PCD without loosing sensitivity. All important parts are made of stainless steel or thermal resistant polymers to guarantee long-term durability.
  •  The Mini-Bio-Plus SCBI can be easily removed and evaluated immediately on completion of each cycle because all outside parts consist of highly thermal resistant polymers that protect hands from high temperatures.
  •  SCBIs also can be used for LTSF-formaldehydesterilization processes without pre-treatment of the biological indicators with NO2SO3, described in EN ISO 11138-5.

Process challenge devices (Bio-C-PCDs) for Mini-Bio-Plus SCBIs)

Incubators