Professional Documents
Culture Documents
a. Topical and non-sterile Inhalations, ointments, creams, Total viable aerobic count- not Transdermal patches: Absence of
respiratory products gels, paste, topical liquids more than 102 micro-organisms Enterobacteriaceae and certain other
(aerobic bacteria plus fungi) per gram-negative bacteria, determeined
gram, per millimeter, or per patch on 1 patch
(including the adhesive and Other preparations: not more than 101
backing layer) Enterobacteriaceae and certain other
gram-negative bacteria per gram or
millimeter
Absence of Pseudomonas
aeuruginosa (1 g, 1 mL, 1 patch)
Absence of Staphylococcus aureus (1
g, 1 mL, 1 patch)
b. Oral and rectal products Lozenges, capsules, Total viable aerobic count- not Absence of Escherichia coli (1 g or
suppositories more than 103 bacteria and not mL)
more than 102 fungi per gram or
millimeter
c. Oral products containing Camphor, caffeine, pilocarpine Total viable aerobic count- not Absence of Escherichia coli (1 g)
raw materials of natural origin more than 104 bacteria and not Absence of Staphylococcus aureus(1
more than 102 fungi per gram or g)
millimeter Absence of Salmonella (10 g)
Not more than 102Enterobacteriaceae
and certain other gram-negative
bacteria (1 g)
d. Herbal remedies made Sage Tea Total viable aerobic count- not Not more than 102 Escherichia coli
with boiling water Ginger Tea more than 107 bacteria and not per gram or millimeter
Thyme Tea more than 105 fungi per gram or
millimeter
e. Other herbal remedies Onion Cough Syrup Total viable aerobic count- not Not more than 103
Garlic Honey more than 105 bacteria and not Enterobacteriaceae and certain other
more than 104 fungi per gram or gram-negative bacteria (1 g)
millimeter Absence of Escherichia coli (1 g)
Absence of Salmonella (10 g)
PREPARATIONS FOR ENVIRONMENTAL
MONITORING
ENVIRONMENTAL MONITORING
● Identifies potential routes of contamination
RECOMMENDED ENVIRONMENTAL MONITORING SITES
AGAR MEDIUM -Violet Red Bile Xylose Lysine -Violet Red Bile Mannitol Salt Agar
Glucose Agar Deoxycholate Agar Glucose Agar (+)
(++indicative) (++indicative) (++indicative)
-MacConkey Agar -Centrimide Agar
(++indicative) (+)
-Centrimide Agar (-
)
-Mannitol Salt Agar
(-)
MEDIUM E.coli Salmonella P. aeruginosa S. aureus
● fever-inducing substances
● harmful or even fatal if administered to humans above certain
concentrations
LAL TEST (limulus amebocyte lysate testing)
● Bacterial endotoxin testing
● in vitro assay
● detect the presence and concentration of bacterial endotoxins in drugs and biological products
Endotoxins
● type of pyrogen
● lipopolysaccharides present in the cell walls of gram-negative bacteria
● react with limulus amebocyte lysate
LAL Test