Non-Sterile Products

Total Aerobic Count (TAC)
Total Combined Yeast and Mold Count
Test for Specified Microorganisms

Microbial Enumeration Test

Total Aerobic Count (TAC)

- Indicator of bacterial populations in a sample.
- Can be used to measure sanitary quality, organoleptic acceptability, adherence to GMP, and safety.
- Amount of microorganisms is expressed in colony forming units per gram (cfu/g) or per ml (cfu/ml)

- Tryptone Soya Broth, Soybean Casein Digest Broth or Tryptic Soy Broth
- Tryptone Soya Agar, Soybean Casein Digest Agar or Tryptic Soy Agar

Medium of Total Aerobic Count (TAC)

30-35°C for 18-24 hours

Setting of Total Aerobic Count (TAC)

- Pour plate method
- Streak plate method

Methods for inoculation used:

- Potato Dextrose Agar/Broth
- Sabouraud Dextrose Agar/Broth

Medium of Total Combined Yeast and Mold Count

20-25°C for 2-3 days

Settings of Total Combined Yeast and Mold Count

Absence of Escherichia coli
Absence of Salmonella spp
Absence of Staphylococcus aureus
Absence of Pseudomonas aeruginosa

Example of Test for Specified Microorganisms

Absence of Escherichia coli

Test for Specified Microorganisms
Particularly important in oral preparations

Absence of Staphylococcus aureus

Test for Specified Microorganisms
Particularly important in topical preparations

MacConkey Agar Medium
Eosin/ Methylene Blue (EMB) Aga

Medium of Test for Specified Microorganisms
Absence of Escherichia coli

Dark Pink

Medium of Test for Specified Microorganisms (Absence of Escherichia coli)
MacConkey Agar Medium

Greenish Metallic Sheen

Medium of Test for Specified Microorganisms (Absence of Escherichia coli)
Eosin Methylene Blue (EMB) Agar

Brilliant Green Agar Medium
Xylose-Lysine Desoxycholate Agar Medium
Bismuth Sulfite Agar Medium

Medium of Test for Specified Microorganisms
Absence of Salmonella spp

Pink to White Opaque (frequently surrounded by pink to red zone)

Medium of Test for Specified Microorganisms (Absence of Salmonella spp)
Brilliant Green Agar Medium

Red, with or without black centers

Medium of Test for Specified Microorganisms (Absence of Salmonella spp)
Xylose-Lysine Desoxycholate Agar Medium

Black or Green

Medium of Test for Specified Microorganisms (Absence of Salmonella spp)
Bismuth Sulfite Agar Medium

Mannitol Salt Agar Medium
Vogel-Johnson Agar Medium
Baird-Parker Agar Medium

Medium of Test for Specified Microorganisms
Staphylococcus aureus

Yellow Colonies with Yellow Zones

Medium of Test for Specified Microorganisms (Staphylococcus aureus)
Mannitol Salt Agar Medium

Black surrounded by yellow zones

Medium of Test for Specified Microorganisms (Staphylococcus aureus)
Vogel-Johnson Agar Medium

Shiny Black Color

Medium of Test for Specified Microorganisms (Staphylococcus aureus)
Baird-Parker Agar Medium

Cetrimide Agar
Pseudomonas Agar Medium for Detection of Fluorescein
Pseudomonas Agar Medium for Detection of Pyocyanin

Medium of Test for Specified Microorganisms
Pseudomonas aeruginosa

Greenish
Greenish

Characteristic Colonial Morphology/Fluorescence in UV Light
Cetrimide Agar

Colorless to Yellowish-Green
Yellowish Green

Characteristic Colonial Morphology/Fluorescence in UV Light
Pseudomonas Agar Medium for Detection of Fluorescein

Blue
Blue

Characteristic Colonial Morphology/Fluorescence in UV Light
Pseudomonas Agar Medium for Detection of Pyocyanin

Friability Test

- Used to test the durability of tablets during packing processes and transit.
- Uses friabilator
- This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum.
- Defined as the % of weight loss by tablets due to mechanical action during the test.
- Tablets are weighed before and after testing and friability is expressed as percentage loss on the tablet weight.
- For compressed, uncoated tablets

If tablet weight is ≤ 650mg: 6.5 grams
If tablet weight is > 650mg: 10 Tablets

Sample Size for Friability Test

25 rpm; 100 revolutions

Settings for Friability Test

NMT 1% weight loss

Acceptance Criteria of Friability Test

Disintegration

- Is the process of conversion from a solid form into granules or aggregates.
- Required for all tablets, capsules, and suppositories

True

TRUE OR FALSE
Disintegration does not imply complete solution of the unit or even its active constituent.

Complete Disintegration

- A state in which no residue is present on the screen of the apparatus after testing.
- Any residue of the unit is a soft mass having no palpably firm core.

- Apparatus: Basket Rack Assembly
- 1000 mL beaker
- 37 ± 2°C
- 29-32 cycles/min
- Upward distance: ≥ 15mm from surface of medium
- Downward distance: ≥ 25 mm from the bottom of the beaker

Settings of Disintegration Testing

Dissolution Testing

- Is defined as the process by which solid substances enters in solvent to yield a solution or the process by which a solid substance dissolves.
- Rate-limiting step before the drug appears on the blood.

- Physicochemical characteristic of the dosage form
- The wettability of the dosage unit
- Penetration ability of the dissolution medium
- Swelling process
- Disintegration
- Deaggregation of the dosage form

Factors that influence the dissolution characteristics of drugs:

37 ± 0.5°C

Temperature for Dissolution Testing
Withdraw specimen midway between the surface of dissolution medium and top of apparatus, and not less than 1 cm from vessel wall.

Tolerance (Q)

Amount of dissolved active ingredient; specified in the individual monograph.

6

How many number of sample in Step 1?

Each unit is NLT Q + 5%

ACCEPTANCE CRITERIA FOR STEP I

Additional 6

How many number of sample in Step II?

Average of 12 units (Stage I & II) ≥ Q and no unit less than Q – 15%.

ACCEPTANCE CRITERIA FOR STEP II

Additional 12

How many number of sample in Step 3?

Average of 24 units (I, II, & III) is ≥ Q, NMT 2 units less than Q – 15%, and no unit less than Q – 25%.

ACCEPTANCE CRITERIA FOR STEP III