VERIFIKASI BIOBURDEN

Preparation of the Samples

Inoculation and Dilution
Neutralization or Removal of Antimicrobial Activity
Common Neutralizing Agents/Methods for Interfering
Substances
Recovery of Microorganisms in the Prsesence of the
Product
Result and Interpretation
Acceptance Criteria

No Parameter Acceptance Criteria

1 Specificity No inhibitory between sample and negative control

2 Accuracy % Recovery : 50 -200 %

3 Precision RSD ≤ 35%

% Recovery : 50 -200 %
4 Robustness
p-value > 0.5
Positive Control
• Prepare @200 mL sample, then spike the sample with
microbe as positive control
• Filter through membrane filter
• Incubate the sample
Specificity
• Prepare @200 mL sample, then spike the sample with
microbe as positive product control
• Filter through membrane filter
• Incubate the sample
• Observe tesult and count % recovery
Accuracy & Precision
• Prepare @200 mL WFI as negative
control
• Prepare @200 mL sample, then
spike the sample with microbe (or Picture 1. Percentage Recovery Calculation
using positive control)
• Filter through membrane filter
• Incubate the sample
• Observe tesult and count %
recovery
• For accuracy, observe result and
count percentage recovery in
Picture 1. For precision, RSD and
SD is calculated in Picture 2 Picture 2. SD and RSD calculation
Robustness
TERIMAKASIH