Standard Operating Procedure (SOP) for Procurement, Storage, and Handling of Biological Indicators
1.0 Objective:
The objective of this SOP is to provide guidelines for the procurement, storage, and handling of biological indicators to ensure their integrity and effectiveness in validating sterilization processes.
2.0 Scope:
This SOP applies to all personnel involved in the procurement, storage, and handling of biological indicators in [Company/Organization Name].
3.0 Responsibilities:
Procurement: The [Designated
Personnel/Department] is responsible for procuring biological indicators from
approved suppliers.
Storage: The [Designated Personnel/Department]
is responsible for the proper storage of biological indicators.
Handling: All personnel involved in
the handling of biological indicators must follow the guidelines outlined in
this SOP.
4.0 Procurement:
4.1. Identify approved suppliers
based on their reputation, regulatory compliance, and product quality.
4.2. Review and compare supplier
specifications, including population of viable microorganisms, resistance
characteristics, and incubation requirements.
4.3. Select the supplier based on
the criteria mentioned above.
4.4. Place the purchase order for the required quantity of biological indicators.
5.0 Receipt and Inspection:
5.1. Upon receipt of biological
indicators, check the shipment for any signs of damage or tampering.
5.2. Verify the received quantity
against the purchase order.
5.3. Inspect the packaging's
integrity and ensure it is intact.
5.4. If any discrepancies or damage are identified, notify the supplier and relevant personnel immediately.
6.0 Storage:
6.1. Store biological indicators in
a designated area specifically allocated for this purpose.
6.2. Maintain a controlled
temperature between 2°C and 8°C (36°F and 46°F) unless otherwise specified by
the manufacturer.
6.3. Ensure that the storage area is
clean, well-organized, and free from potential sources of contamination.
6.4. Protect biological indicators
from exposure to light by storing them in opaque containers or packaging.
6.5. Follow the manufacturer's
recommendations regarding humidity, if applicable.
6.6. Clearly label and segregate different batches or types of biological indicators to prevent mix-ups.
7.0 Handling:
7.1. Only trained personnel should
handle biological indicators.
7.2. Wash hands thoroughly with
soap and water before and after handling biological indicators.
7.3. Wear appropriate personal
protective equipment (PPE), such as gloves, lab coat, and eye protection, when
handling biological indicators.
7.4. Follow aseptic techniques to
minimize the risk of contamination during handling.
7.5. Adhere to the recommended
incubation conditions and duration specified by the manufacturer.
7.6. Document all handling activities, including dates, times, and any relevant observations or deviations.
OR
7.7Transfer two ampoules of biological
indicators aseptically to the sterility room under Laminar Flow Hood (LFH)
conditions.
7.8 Adhere to the appropriate gowning
procedure for accessing the sterile testing area of the microbiological testing
room.
7.9 Carefully open the ampoule
containing Geobacillus Stearothermophilus spores under LFH and transfer the
contents into a pre-sterilized glass Petri plate.
7.10 Pour 20-25ml of agar into the Petri
plate, ensuring that the agar covers the spores evenly, and allow the plate to
solidify.
7.11 Place the prepared plate in an
incubator at a temperature of 55°C for 48 hours to facilitate bacterial growth.
7.12 If any unused biological indicators
remain after the expiration date, dispose of them by subjecting them to a moist
heat sterilization cycle at 121°C/15psi/15 minutes.
7.13 Accurately record the autoclaving activity and disposal details in the respective logbooks.
8.0 Disposal:
8.1. Dispose of biological
indicators according to applicable regulations and waste management protocols.
8.2. Follow the manufacturer's
instructions or guidelines for the safe disposal of used biological indicators.
8.3. Clearly label and segregate waste containers for biological indicators to prevent accidental exposure or mix-ups.
9.0 Training and Documentation:
9.1. Provide training to personnel
involved in the procurement, storage, and handling of biological indicators.
9.2. Maintain records of procurement,
storage, handling, and disposal activities for traceability and audit purposes.
9.3. Regularly review and update this SOP as necessary to ensure compliance with regulatory requirements and industry best practices.
Note: This SOP should be followed in conjunction with any additional guidelines or regulations specific to your industry or organization.
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