procedure for Personnel monitoring

1.0 Objective
To lay down a procedure for Personnel monitoring.
2.0 Scope
This Standard Operating Procedure is applicable for the Personnel monitoring to be followed at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control Department are responsible for preparation of this SOP.
4.0 Abbreviations and Definitions
QA : Quality Assurance
IPA : Isopropyl Alcohol.
RODAC : Replicating Organism Detection And Count
SCDA : Soybean Casein Digest Agar.
Dia. : Diameter
MM : Millimeter
SCDA : Soyabean Casein Digest Agar
RH : Right Hand
LH : Left Hand
LAF : Laminar Air Flow
5.0 Procedure
5.1 Take required quantity of SCDA agar filled sterile RODAC plates for individual and SCDA

filled prepared Petri plates (90mmdia.) depending on the number of persons and also locations of

monitoring. RODAC plates are used for monitoring body surface area of a person while the SCDA

filled 90mm dia. Petri plates are used for finger dab test for both hands of a person.
5.2 Mop the SS container outer surface with 70% IPA solution with the help of cloth and place all

mopped RODAC/flexi plates in SS container & transfer the SS container to sterile area either through

pass box or change room.
5.3 Allow the SS Container containing contact plate as well as SCDA filled Petri plates either to

remain under UV in pass box as per area requirement before transferring inside sterile area.
5.4 Now enter the sterile area as per entry and exit SOP of respective area.
5.5 Open the lid of SS container and mark properly each contact plate as well as the Petri plate with the

name of the person, date of monitoring and the location properly with the help of marker.
5.6 RODAC plates and SCDA filled Petri plates are required for each person for personnel monitoring.
5.7 Open aseptically Contact Flexi/RODAC plate lid and sample by gently touching the media of the plate

to the desired location in such a way, that the whole media surface of the flexi/RODAC plate should touch

the sampling location (except finger dab)
5.8 Do not press the RODAC plate against surface hardly as it may cause the breakage of the media.

Close the lid of the plates immediately after sampling and mop immediate the sampled area with 70% IPA.
5.9 Take SCDA filled Petri plate and mark similarly the name of the person, date of sampling and also mention

Right Hand as RH as well as Left Hand as LH with the help of marker pen.
5.10 Place the tip of all the five fingers of each hand simultaneously including thumb on the surface of

the solidified agar under LAF gently in such a manner that it should touch the surface of the media without damage.
5.11 Replace the lid of the Petri plate immediately after finger dab sampling & now keep all plates as well as

Petri plates inside the cleaned SS container & transferred to Microbiology lab through either pass or

change room for incubation.
5.12 All the sampled plates are incubated in inverted position at 20oC-25oC for 3 days and then incubated

at 30oC-35oC for 2 days along with negative control. After incubation observe and count the number of

colony forming units obtained per plate.
5.13 Record the observations in an authorized format. Personal monitoring of the personal is done daily

once in one operational shift of production and daily for the operating microbiologist performing

sterility test. Deviation should be reported to immediate senior for its thorough investigation.
5.14 In personnel monitoring the action limit and alert limit of cfu per contact flexi plate for forehead,

chest and RH and LH armpits of a person under monitoring in sterile area should not be more as

specified on observation format. The action limit and alert limit of finger dab test should not be more

than specified on observation format.
6.0 Forms and Records
6.1 Format for Personnel monitoring in Aseptic Area – Annexure-1
6.2 Format for Personnel monitoring in sterility Testing Area – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History