Nothing Special   »   [go: up one dir, main page]

Cleaning Validation Process

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 11

List of Equipment in Production Area.

S.N Equipment Location


O
1 High Speed Granulator Mixing Granulation area (Ground Floor)
2 Double Cone Blender Granulation area (Ground Floor)

3 Fluid Bed Dryer Granulation area (Ground Floor)


4 Oscillating Granulator Granulation area (Ground Floor)

5 Rotary Tablet Machine (ZP-17) Compression area


(Ground Floor)
6 Compression Machine China (ZP-31) Compression area
(Ground Floor)
7 Coating Pan 36” Diameter Coating area
(Ground Floor)
8 S.S Pressure Vessel for Coating Solution Coating area
(Ground Floor)
9 Coating Stand with sprayer Coating area
(Ground Floor)
10 Double Cone Blender Capsule Blending area
11 Encapsulation Machine (Semi-Automatic) Encapsulation area
12 Capsule Polisher Capsule Blending area
13 Cream Manufacturing vessel with Mixer & Homogenizer Semi solid Manufacturing area
14 Olsa Mixer & Homogenizer Semi solid Manufacturing area

15 Cream Manufacturing vessel with Mixer & Homogenizer Semi solid Manufacturing area

16 Variable Speed Stirrer Semi solid Manufacturing area

17 Steam Jacketed Kettle 200Ltr Semi solid Manufacturing area


18 Steam Jacketed Vessel 50Ltr Semi solid Manufacturing area

19 Coating Pan Tool Room


20 Tube Filling Machine Tube Filling Area
21 Fluid Bed Dryer Granulator Granulation area (first floor)
22 Cone Blender Local Granulation area (first floor)
23 Rotary Tablet Machine Compression area (first floor)

24 Film Coating Machine (Thai Coater) Coating (first floor)


25 Z - Mixer Granulation (First Floor)
S.N
Marketed Product Generic Solubility Toxicity
O
Creams
Freely soluble in dehydrated alcohol,
methanol, slightly soluble in acetone,
1 Ademac 1% Cream Terbinafine HCL Not Available
very slightly or slightly soluble in
water.
Freely soluble in 30% ammonia
solution, slightly soluble in acetone,
2 Antiburn 1%Cream Silver Sulphadiazine Not Available
practically insoluble in alcohol,
chloroform & ether.
Freely soluble in water, alcohol &
3 Clearderm 2% Cream Hydroquinone Not Available
ether.
Freely soluble in water, alcohol &
4 Clearderm 4% Cream Hydroquinone Not Available
ether.
Tablets
Freely soluble in dehydrated alcohol,
Ademac 250mg methanol, slightly soluble in acetone,
1 Terbinafine HCL Not Available
Tablet very slightly or slightly soluble in
water.
Effects and birth defects (teratogenic).
May cause skin irritation, eye &
Respiratory Tract irritation & digestive
tract irritation with abdominal pain,
nausea, vomiting, diarrhea or
Soluble in diluted hydrochloric acids, decreased motility or constipation.
2 Aclova 400 mg Tablet Acyclovir slightly soluble in water, insoluble in May affect behaviour/central nervous
ethanol. system, brain, respiratory system,
blood, urinary system. Other
symptoms may include sore throat,
thirst, muscle cramps, perspiration.
Ingestion: Prolonged or repeated
ingestion may affect the urinary
system and metabolism (anorexia).
3 Aclova 800 mg Tablet Acyclovir Soluble in diluted hydrochloric acids, Effects and birth defects (teratogenic).
slightly soluble in water, insoluble in May cause skin irritation, eye &
ethanol. Respiratory Tract irritation & digestive
tract irritation with abdominal pain,
nausea, vomiting, diarrhea or
decreased motility or constipation.
May affect behaviour/central nervous
system, brain, respiratory system,
blood, urinary system. Other
symptoms may include sore throat,
thirst, muscle cramps, perspiration.
Ingestion: Prolonged or repeated
ingestion may affect the urinary
system and metabolism (anorexia).
Soluble in Dimethylformamide, slightly
soluble in acetone, very slightly soluble
4 Aponip 7.5mg Tablet Meloxicam Not Available
in methanol and alcohol, practically
insoluble in water.
Soluble in Dimethylformamide, slightly
soluble in acetone, very slightly soluble
5 Aponip 15mg Tablet Meloxicam Not Available
in methanol and alcohol, practically
insoluble in water.
No irritating effect on the skin & eyes.
Soluble in acetone & in methylene Sensitization effect through inhalation
chloride, slightly soluble in dehydrated is possible with prolonged exposure.
6 Arket 250mg Tablet Clarithromycin alcohol, in methanol, acetonitrile & in This product contains antibiotics.
phosphate buffer at PH value of 2 to 5, People with known allergies should
practically insoluble in water. use appropriate safety precautions
when handling.
No irritating effect on the skin & eyes.
Soluble in acetone & in methylene Sensitization effect through inhalation
chloride, slightly soluble in dehydrated is possible with prolonged exposure.
7 Arket 500mg Tablet Clarithromycin alcohol, in methanol, acetonitrile & in This product contains antibiotics.
phosphate buffer at PH value of 2 to 5, People with known allergies should
practically insoluble in water. use appropriate safety precautions
when handling.
Practically insoluble in water, slightly
or sparingly soluble or sparingly
8 Bropam 3mg Bromazepam Not Available
soluble in ethanol & in methylene
chloride.
Very slightly soluble in water, soluble
9 Depam 10mg Diazepam Not Available
in ethanol.
Practically insoluble in water, sparingly
10 Loram 2mg Lorazepam soluble in ethanol, sparingly or slightly Not Available
soluble in methylene chloride
Paracetamol: Slightly hazardous in
case of skin contact(irritant), of
ingestion, of inhalation. Excreted in
maternal milk in human.
Tramadol: LD50 is 1028mg/kg in rats
and 1137mg/kg in mice.
Paracetamol & Freely soluble in alcohol, soluble in
11 Campex P Tablet Carcinogenicity observed in mice.
Tramadol boiling water & in 1N NaOH.
Ocular symptoms: (burning,
discharge, conjunctivitis observed
after administration of therapeutic
dose. Patients with COPD or history of
Cardiac disease should not be
exposed to tramadol hydrochloride.
12 Citapam 10mg Tablet Escitalopram Freely soluble in methanol & dimethyl Toxicological Properties have not
sulfoxide, sparingly soluble in water been thoroughly investigated.
and in alcohol very slightly soluble in However harmful if swallowed in large
ethyl acetate and in isopropyl alcohol, amount, causes irritation if it contacts
insoluble in heptane. with eyes.
Harmful if swallowed, inhaled, or
absorbed through skin.
Soluble in Dimethyl sulfoxide and in
May cause eye, skin irritation.
acetic acid, sparingly soluble in water,
13 Floquin 250mg Tablet Levofloxacin May cause allergic respiratory and
acetone & in methanol, practically
skin reactions.
insoluble in glycerin.
Sensitization effect by skin contacting
is possible with prolonged exposure.

Harmful if swallowed, inhaled, or


absorbed through skin.
Soluble in Dimethyl sulfoxide and in May cause eye, skin irritation.
acetic acid, sparingly soluble in water, May cause allergic respiratory and
14 Floquin 500mg Tablet Levofloxacin
acetone & in methanol, practically skin reactions.
insoluble in glycerin. Sensitization effect by skin contacting
is possible with prolonged exposure.

15 Itide 50mg Tablet Itopride HCL Very soluble in water. Not Available
Soluble in 0.1N NaOH, sparingly Acute Oral Toxicity: Oral, rat
soluble in water, methanol, slightly LD50=980mg/kg
soluble in 0.1N HCl, Not found any other toxicity with
dimethylformamide, in alcohol, respect to skin, eyes & Reproduction.
16 Moftab 400mg Tablet Moxifloxacin
practically insoluble in methylene
chloride, acetone, ethyl acetate,
toluene. Insoluble in tert-butyl methyl
ether & heptane
17 Sigmar 10 mg Tablet Ebastine Practically insoluble in water, very Inhalation: May be harmful if inhaled.
May cause respiratory tract irritation.
Ingestion: May be harmful if
swallowed.
soluble in methylene chloride,
May cause eye irritation.
sparingly soluble in methanol.
May be harmful if absorbed through
skin. May cause skin irritation.

Practically insoluble in water, sparingly


soluble in methanol & slightly soluble LD50 oral -rat-2.60mg/kg skin
18 Sulpy 25 mg Tablet Levosulpride corrosion/irritation.
in ethanol (96%) & in methylene
chloride. Respiratory or skin sensitization

Practically insoluble in water, sparingly


soluble in methanol & slightly soluble LD50 oral -rat-2.60mg/kg skin
19 Sulpy 50mg Tablet Levosulpride corrosion/irritation.
in ethanol (96%) & in methylene
chloride. Respiratory or skin sensitization

Slightly hazardous in case of skin


contact(irritant) of ingestion, of
Sparingly soluble in water, slightly inhalation.
soluble in acetic acid and in methanol, May cause dermatitis. May cause eye
Tenacid 250 mg
20 Ciprofloxacin very slightly soluble in dehydrated irritation with itching, burning
Tablet
alcohol, practically insoluble in acetone sensation, tearing, decreased vision.
and acetonitrile. May also cause conjunctival
hyperemia, keratitis, keratopathy, lid
edema, photophobia.
21 Tenacid 500mg Ciprofloxacin Sparingly soluble in water, slightly Slightly hazardous in case of skin
Tablet soluble in acetic acid and in methanol, contact(irritant) of ingestion, of
inhalation.
May cause dermatitis. May cause eye
very slightly soluble in dehydrated irritation with itching, burning
alcohol, practically insoluble in acetone sensation, tearing, decreased vision.
and acetonitrile. May also cause conjunctival
hyperemia, keratitis, keratopathy, lid
edema, photophobia.
Capsules
Chronic effects on Human: May cause
damage to the GI Tract, in case of
long-term exposure.
Anvitoff 20mg Acute Potential Health Effect:
1 Esomeprazole N/A in COA
Capsule Skin: May cause skin irritation.
Eyes: Dust may cause eye irritation.
Inhalation: Dust may cause
respiratory tract irritation.
Chronic effects on Human: May cause
damage to the GI Tract, in case of
long-term exposure.
Anvitoff 40mg Acute Potential Health Effect:
2 Esomeprazole N/A in COA Skin: May cause skin irritation.
Capsule
Eyes: Dust may cause eye irritation.
Inhalation: Dust may cause
respiratory tract irritation.

Sparingly soluble in water, slightly Inhalation Toxicity (LC 50) value


Ezoside 4 mg greater than 2mg/L is reported.
3 Thiocolchicoside soluble in ethanol, practically insoluble
Capsules Acute oral toxicity (LD50):27.5mg/kg
in acetone.
(IM Rat)
Sparingly soluble in water, slightly Slightly hazardous in case of skin
Mecomin 500 µg
4 Mecobalamin soluble in ethanol and practically contact (irritant), of ingestion
Capsules
insoluble in acetonitrile. inhalation.
May cause damage to GIT, in case of
long-term exposure.
Hazardous in case of inhalation (lung
Nexole 30 mg Lansoprazole
5 N/A in COA irritant)
Capsules Pellets
Slightly hazardous in case of skin
contact (irritant).

Acute oral Toxicity 1271mg/kg (Rat).


Freely soluble in methanol, soluble in Slightly hazardous in case of skin
Alcohol and in acetone, sparingly contact (irritant), of ingestion, of
Olonzo 150mg
6 Fluconazole soluble in isopropanol & chloroform, inhalation.
Capsule (1's) (4’s)
slightly soluble in water, very slightly May cause birth defects(teratogenic).
soluble in toluene. May cause RT irritation, digestive tract
irritation.
7 Ramezol 20 mg Omeprazol N/A in COA May cause damage to GIT, in case of
Capsule long-term exposure.
Hazardous in case of inhalation (lung
irritant)
Slightly hazardous in case of skin
contact (irritant).
May cause adverse reproductive
effects based on animal data.
May affect genetic material. May
cross the placenta.
Dust may cause eye irritation.
May cause digestive tract irritation
with nausea, vomiting, hypermotility
and diarrhea. May also affect blood
(eosinophilia, Normocytic anemia),
metabolism, brain, behavior (ataxia,
convulsions, sedation, change in
motor activity, decreased activity),
respiration (dyspnea, coughing,
decreased respiration, pleural
effusion, ptosis), liver (jaundice,
hepatitis), immune system, urinary
system/kidneys, and cause
musculoskeletal effects.

8 Ramezol 40 mg Omeprazol N/A in COA May cause damage to GIT, in case of


Capsule long-term exposure.
Hazardous in case of inhalation (lung
irritant)
Slightly hazardous in case of skin
contact (irritant).
May cause adverse reproductive
effects based on animal data.
May affect genetic material. May
cross the placenta.
Dust may cause eye irritation.
May cause digestive tract irritation
with nausea, vomiting, hypermotility
and diarrhea. May also affect blood
(eosinophilia, Normocytic anemia),
metabolism, brain, behavior (ataxia,
convulsions, sedation, change in
motor activity, decreased activity),
respiration (dyspnea, coughing,
decrease, respiration, pleural effusion,
ptosis), liver (jaundice, hepatitis),
immune system, urinary
system/kidneys, and cause
musculoskeletal effects.
Acute Oral toxicity (LD50) >
2000mg/kg (rat).
May cause eye irritation,
Practically insoluble in water, freely conjunctivitis.
Zonacin 250 mg
9 Azithromycin soluble in ethanol & in methylene May cause skin irritation.
Capsules
chloride May cause respiratory tract irritation.
May cause GIT irritation.

You might also like