Microbial Mapping of Personnel in Class D Areas: A Risk-Based Approach to Glove Monitoring

 

Microbial Mapping of Personnel in Class D Areas: A Risk-Based Approach to Glove Monitoring 

The “finger-dab test” is a critical, routine environmental assessment tool utilized in the Class D Manufacturing Environment (typically GMP Grade D or ISO-8), which assists in gauging the efficacy of personnel hygiene and cleaning methodologies. While there are no defined maximums by WHO TRS No. 961 for finger-dabs collected from Class D Manufacturing Facilities, most in-house action limits are established at 100 CFU (Colony Forming Units) from 5 fingerprints collected per operator.

1.      Objectives: To determine the risk

of an increase in microbial load within finished products through manufacturing personnel during the formulation process.

2.      Study Design:

a. Design and Implementation: 1-day study completed during processing time in Class D Areas.

b. Media used: Soybean casein digest agar

c. Incubation temperature: 35°C.

d. Incubation time: 72 hours.

All samples must be collected from the Classified Areas (Class D)

 3.. Criteria for Sampling:

 1. Total samples in processing areas

2. Samples taken from right and left hands of 10 operators.

  4. Sites of Sample Collection:

 a. Granulation Room

 b. Compression Room

 c. Suspension Preparation Room

 d. Coating Room e.

Tablet Inspection Room

      5. Methods of Sample Selection

Random sampling method.

 6. Sample Collection & Analysis 

The sterile culture medium, Soybean Casein Digest Agar, was opened in the specified area; the operators were asked to gently place all five fingers of their right and left hands, respectively, in two different petri dishes. The dishes were then labeled "Right hand," "Left hand," Employee Code, and Date. A total of 20 Soybean Casein Digest Agar plates were sampled and transported to the Microbiology laboratory for analysis. Samples were incubated at 35°C for 72 hours, after which results were recorded.

6.Result

S. No Code No. TAMC(Cfu /Plate) TAMC(Cfu /Plate) Right Hand Left Hand 1 A 13 70 2 B 89 87 3 C 34 28 4 D 40 56 5 E 48 58 6 F 49 49 7 G 86 101 8 H 98 97 9 I 37 88 10 J 67 93

The operators succeeded in the finger test with <100 CFU on both the right and left hands when performing formulation activities in Class D work areas. However, the results are approaching the alarming limit for Class D areas of WHO TRS No. 961 Environmental Monitoring Limits. A microbial limit test is applied to non-sterile products, and the hygiene of the operators' hands plays an important role in preventing product contamination. The data demonstrate that the probability of the operator transferring their contaminating load onto the glove is high, resulting in increased microbial contamination of the end product and raising potential concerns for consumer safety.

8. Conclusion

1. Operators with high microbial loads on gloves put products at risk by adding microbes to finished products.

2. Proper methods to sanitize gloves among operators are essential to meeting the requirements for safety and quality products.

9. Recommendation

During the next revision of the regulatory guidelines for Environmental Monitoring, regulatory organizations globally, including the WHO, should make the Finger Dab Test mandatory for formulation areas in Class D and specify allowable limits for the test in the revised guidelines.