Your Compass for Pharma Success

EQUIPMENT MONITORING BY SWAB AND RINSE BIOLOAD METHOD

  • PROCEDURE FOR THE EQUIPMENT MONITORING BY SWAB AND RINSE BIOLOAD METHOD:
EQUIPMENT MONITORING BY SWAB AND RINSE BIOLOAD METHOD
  • Equipment Bio load:
  • By Swab Method:
  • Sterilize the non-sterile swab stick in 20 mL of normal saline with 0.5% Soya lecithin with 1% Polysorbate 80 in a test tube plugged with non-absorbent cotton/plastic cap and sterilize in an Autoclave as per validated cycle.
  • Pre sterilized readymade swabs can also be used.
  • Note: Before transferring to sampling location add aseptically 20 mL of normal saline with 0.5% Soya lecithin with 1% Polysorbate 80, incase of ready prepared swab stick are used.
  • Carry the sterilized swabs in a stainless steel box, previously wiped with 70% v/v IPA to the respective area.
  • Refer respective cleaning validation protocol for swab sampling locations.
  • Press the swab with a rolling motion against the side of the glass tube to remove excess saline, Swab an area of approximately 25cm2 (5×5 cm) of the equipment, first with horizontal strokes followed by vertical strokes as per Figure-1.
Swab Technique
  • The swab is mixed in the saline by swirling vigorously. Label the tube with the equipment name/ID, designated location and date. Transfer the swabs samples to the microbiology department.

Note: In case any delay in analysis, store the swab samples at 2-8°C. The time elapsing between collection and examination should not exceed 72 hours. If stored at 2-8°C, allow the samples to attain the ambient temperature before analysis.

  • After thorough mixing of the swab samples, filter 10 ml of saline each through 0.45 µm sterile membrane filters and rinse with 100 ml of 0.1 % sterile peptone water and place in SCDA.
  • Incubate the SCDA plates at 20-25°C for 72 Hrs. followed by 30-35°C for further 48 Hrs. After completion of incubation count the colonies by using colony counter and record the results in Format-II.
  • Number of colonies observed on a membrane X 2.

Example: if two colonies observed on the membrane X 2 = 4 cfu/Swab Here 10 mL used for Total Viable Count another 10 mL used for Pathogen testing.

  • Transfer the remaining 10 mL sample to 90 mL of previously sterilized soya bean casein digest broth with 0.5% Soya lecithin with 1% Polysorbate 80 and incubated at 30-35°C for 18-24 hours.
  • Perform test for specified organisms listed below as per GTP.
  • Frequency: After every ‘type C ’cleaning/Whenever received TRF.
  • Acceptance criteria:
S. No.Test ParameterLimits
1.TVC (TBC+TFC)50 cfu/swab
2.Escherichia coliAbsent/swab
3.Salmonella sppAbsent/swab
4.Staphylococcus aureusAbsent/swab
5.Pseudomonas aeruginosaAbsent/swab
  • Rinse Bio load:
  • After completion of final cleaning rinse the required equipment with specified quantity of water and collect about 100mL of this sample in a sterilized bottle. Label the bottle with the equipment name/ID, designated location and date. Transfer the bottles to the microbiology department.

Note: In case any delay in analysis, store the samples at 2-8°C. The time elapsing between collection and examination should not exceed 72 hours. If stored at 2-8°C, allow the samples to attain the ambient temperature before analysis.

  • Take 10ml of this sample and filter through 0.45mm sterile membrane filters followed by 100 ml of 0.1 % peptone water place in SCDA plate.
  • Incubate the SCDA plates at 20-25°C for 72 Hrs. followed by 30-35°C for further 48 Hrs. Count the number of colonies after completion of incubation.
  • Count the number of colonies observed on filters / Sample volume and report as cfu/mL in Format-II.
  • Take the another 10mL of the sample and transfer to 90mL of previously sterilized soya bean casein digest broth with 0.5% Soya lecithin with 1% Polysorbate 80 and incubated at 30-35°C for 18-24 hours.
  • Perform test for specified organisms listed below as per GTP.
  • Acceptance criteria:
S. No.Test ParameterLimits
1.TVC (TBC+TFC)25cfu/mL
2.Escherichia coliAbsent/10mL
3.Salmonella sppAbsent/10mL
4.Staphylococcus aureusAbsent/10mL
5.Pseudomonas aeruginosaAbsent/10mL
  • Negative control:
  • Negative control shall be perform by filtering with Sterile swab containing with 20 mL sterile saline solution, after filtration rinse with 100ml of 0.1% peptone water.
  • Acceptance criteria: Negative control should not show any growth.
  • Action plan for excursion of Acceptance criteria: If any test result exceeds the specified limits, investigation shall be carried out as per SOP and take necessary corrective action and preventive action (CAPA) shall be taken.
  • ANNEXURES: 
ANNEXURE NO.TITLE OF ANNEXURE
Annexure-IEquipment swab/ Rinse Report
Annexure-IIEquipment swab/rinse raw data report
  • ABBREVIATIONS:
No.:Number
SCD:Soya bean Casein Digest Agar
SCB:Soya bean casein digest broth
cfu:Colony Forming Units
GTP:General test procedure
TRF:Test Request form
IPA:Isopropyl Alcohol
v/v:Volume /volume
TFC:Total Fungal Count
SOP:Standard Operating Procedure
QC:Quality Control

Annexure-I
EQUIPMENT SWAB/ RINSE REPORT

EQUIPMENT SWAB/ RINSE REPORT

Annexure-II
EQUIPMENT SWAB/RINSE RAW DATA REPORT

EQUIPMENT SWAB/RINSE RAW DATA REPORT
Share this article
Shareable URL
Prev Post

DISPOSAL OF CULTURES AND CONTAMINATED MEDIA

Next Post

OPERATION OF COOLING INCUBATOR Make: Newtronic

Leave a Reply

Your email address will not be published. Required fields are marked *

Read next

Discover more from PharmaGuideHub

Subscribe now to keep reading and get access to the full archive.

Continue reading