QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 29

SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:

from samples obtained through the monitoring program or their corresponding ATCC
(American Type Culture Collection) strains. The ability of the selected media to detect and
quantitate these anaerobes or microaerophilic microorganisms can be evaluated.

2. Controls: During routine monitoring, each preparation of media can be tested for posi-
tive control (with 100 CFU) and negative control (open during performing the test).

3. Methodology “according to the type of water.”

a. Pure steam or water for injection.

i. Total aerobic viable count: Using the membrane filtration method, a 100 mL sam-
ple can be filtrated and placed on low-nutrient-content media at 20-22°C for 5 days
and observed for another 2 days.

ii. Bacterial endotoxin: Kinetic test or gel clot limit method “STM MC 000.”

b. Puriied water: There are three types of purified water.

i. Class A purified water: It is used for highly bacteria critical products such as cer-
tain topical, antacids, and inhalants as well as the deionized water itself.

A. Total aerobic viable count: As per STM MC 001 using the membrane filtra-

tion method. A sample of 100 mL can be filtrated and placed on low-nutrient
media, at 20-22°C for 5 days and observed for another 2 days.

B. Pseudomonas: A sample of 100 mL can be filtrated and the membrane filter

is placed in 50 mL of TSB (tryptic soy broth) incubated for 20-28 h at
35 + 2°C. The membrane filter is then transferred into Pseudomonas agar F
and P for 40-48 h at 35 + 2°C. If any characteristic colony is detected, iden-
tify using API and/or automated identification system.

C. Coliform: A sample of 100 mL can be filtrated and, the membrane filter is

placed in 50 mL of MacConkey broth, incubated for 20-28 h at 35 + 2°C.
Later it is transferred into EMB agar for 40-48 h at 35 + 2°C. If any charac-
teristic colony is detected, identify using the API and/or automated
identification system.

ii. Class B purified water used for rinsing: Same as purified water class A except for
microbial limit is 100 CFU/100 mL.

iii. Class C purified water: It has minimum concerns associated with bacteria levels
such as washing water and laboratory usage.

A. Total aerobic viable count: Pour 1 mL into a plate containing 25 mL of tryp-

tone glucose extract agar or TSA 1/2 conc. or 1/2 conc. plate count agar.
Incubate at 22°C/day.

B. Pseudomonas: Pour 1 mL into a plate containing 25 mL of Pseudomonas

agar F or P. Incubate at 35-37°C/2 days.

c. Feed water, RO water, and drinking water: The drinking water depends on the local

availability and is delivered by the municipal or other local public system or drawn
from a private well or reservoir. This water serves as the starting material for most
forms of water.

iii. Total aerobic viable count: Pour 1 mL into a plate containing 25 mL of TSA
1/2conc. or 1/2conc. plate count agar. Incubate at 22°C/5 days.

iii. Pseudomonas: Pour 1 mL into a plate containing 25 mL of Pseudomonas agar F or
P. Incubate at 35-37°C/2 days.

iii. Coliform: Using the membrane filtration technique, filtrate 100 mL and place the
membrane filter into Endo agar and identify using the API and/or automated iden-
tification system.