Product Equipment Train Matrix Tab CapPPS

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

18.1 Products/Equipment Train (Tablets, Capsules, and PPS) 18.1.1 Wet Granulation Uncoated Tablets

Product

Equipments

Paracetamol 500 mg tablets Salbutamol 4 mg tablets Ketotifen tablets Sulfamethoxazole DS tablets Mini glibenclamide tablets Pseudoephedrine tablets Glibenclamide tablets Gliclazide 80 mg tablets Dimenhydrinate tablets Antiflu tablets Chlorohistol maleate tablets Diazepam 5 mg tablets Al-Mg hydroxide tablets Betamethasone 0.5 mg tablets Carbamazepine tablets Gliclazide tablets Indapamide tablets Loratadine tablets Enalapril tablets Furosemide tablets Al-Mg hydroxide plus tablets Orphenadrine/acetamol tablets Amiodarone tablets Diphenhydramine II tablets Bromocryptin tablets Diphenoxylate tablets Paracetamol (dol) tablets Ambroxol 30 mg tablets

Granulator, fluid bed dryer, sifter, tumbler, tablet press A Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press A Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press A Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press A Granulator, fluid bed dryer, sifter, tumbler, tablet press A/B Granulator, fluid bed dryer, sifter, tumbler, tablet press A/B Granulator, fluid bed dryer, sifter, tumbler, tablet press A/B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B/C Granulator, fluid bed dryer, sifter, tumbler, tablet press B/C Granulator, fluid bed dryer, sifter, tumbler, tablet press A/B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press C Granulator, fluid bed dryer, sifter, tumbler, tablet press C Granulator, fluid bed dryer, sifter, tumbler, tablet press C Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press A Granulator, fluid bed dryer, sifter, tumbler, tablet press C

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

Product

Equipments

Tamoxifen tablets Thiamine 100 tablets Norfloxacin tablets

Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B Granulator, fluid bed dryer, sifter, tumbler, tablet press B

18.1.2 Wet Granulation Coated Tablets

Product

Equipments

Bezafibrate 200 mg tablets Granulator, fluid bed

Ibuprofen 600 mg tablets Granulator, fluid bed

Cimetidine 200/400/800 mg Granulator, fluid bed

Erythromycin 500 mg tablets Granulator, fluid bed

Ciprofloxacin 250/500/750 mg tablets Granulator, fluid bed

Cetrizine tablets Granulator, fluid bed

Clarithromycin tablets Granulator, fluid bed

Metformin film-coated tablets Granulator, fluid bed

Lomefloxacin tablets Granulator, fluid bed

Acyclovir tablets Granulator, fluid bed

Attapulgite 150 mg tablets Granulator, fluid bed

Diclofenac 50 mg tablets Granulator, fluid bed

Bromhexine 8 mg tablets Granulator, fluid bed

Famotidine 200 mg tablets Granulator, fluid bed

Ciprofloxacin 500 tablets Granulator, fluid bed

Atenolol 100 mg tablets Granulator, fluid bed

Mebendazole tablets Granulator, fluid bed

Metronidazole tablets Granulator, fluid bed dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, dryer, sifter, tumbler, tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press tablet press

B, cota B, cota B, cota B, cota B, cota B, cota B, cota B, cota B, cota B, cota

A, cota

B, cota A, cota A, cota A, cota A, cota A, cota A, cota

18.1.3 Dry Granulation Uncoated Tablets

Product

Equipments

Prednisolone 20 mg tablets Sifter,

Simethicone 42 mg tablets Sifter,

Vitamin C 500 mg tablets Sifter,

Aspirin 80 mg tablets Sifter,

Metoclopramide 10 mg tablets Sifter,

Pyridoxine 40 mg tablets Sifter,

Folicron 5 mg tablets Sifter,

Propranolol 40 mg tablets Sifter,

Captopril tablets Sifter,

Ranitidine 300 mg tablets Sifter,

Multivitamin tablets Sifter, tumbler, tablet press A tumbler, tablet press A tumbler, tablet press A tumbler, tablet press B tumbler, tablet press A/B tumbler, tablet press A tumbler, tablet press A tumbler, tablet press A tumbler, tablet press A tumbler, tablet press A tumbler, tablet press A

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

18.1.4 Dry Granulation Coated Tablets

Product

B-complex tablets Ranitidine 300 mg tablets Multivitamin M tablets

18.1.5 Sugar-Coated Tablets

Equipments

Sifter, tumbler, tablet press A, cota Sifter, tumbler, tablet press A, cota Sifter, tumbler, tablet press A, cota

Product

Equipments

Hyoscine S/C tableSts Bisacodyl 5 mg tablets Sennoside S/C tablets Ibuprofen 200 mg tablets

Granulator, fluid bed dryer, sifter, tumbler, tablet press B, sugar-coating pan Granulator, fluid bed dryer, sifter, tumbler, tablet press B, sugar-coating pan Granulator, fluid bed dryer, sifter, tumbler, tablet press A, sugar-coating pan Granulator, fluid bed dryer, sifter, tumbler, tablet press B, sugar-coating pan

In the above tables, products and the corresponding equipment train lists for tablets, manufactured in the ABC Pharmaceutical Company, were identified. Based on these matrices, the worst-case product for each piece of equipment will be chosen to conduct cleaning validation.

As discussed above, for each piece of equipment, more than one product will be chosen based on less solubility of excipients, high toxicity of APIs, and maximum therapeutic dose.

18.2 Product/Equipment Train (Capsules)

Product

Equipments

Indomethacin 25 mg

Sifter, encapsulator A

Tetracycline 250 mg

Sifter, encapsulator A

Oxytetracycline 250 mg

Sifter, encapsulator A

Doxycycline 100 mg

Sifter, encapsulator A

Fluoxitin

Sifter, encapsulator A

Azythromycin 250 mg

Sifter, encapsulator A

Oseltamivir 75 mg

Sifter, encapsulator A

Omeprazole 40 mg

Sifter, encapsulator B

Carbinoxamine

Sifter, encapsulator B

Erythromycin 250 mg

Sifter, encapsulator B

Lansoprazole 30 mg

Sifter, encapsulator B

Theophylline 300 mg

Sifter, encapsulator B

Folic acid/iron

Granulator, sifter, encapsulator B

Your Company's Logo ) Company's Name

18.3 Product/Equipment Train (Granules)

Product Equipments

Erythromycin 200 mg/mL Granulator, fluid bed dryer, sifter, powder filling machine

Oseltamivir 12 mg/mL Granulator, sifter, powder filling machine

Azythromycin 200 mg/5 mL Granulator, sifter, powder filling machine

Was this article helpful?

0 0
Coping with Asthma

Coping with Asthma

If you suffer with asthma, you will no doubt be familiar with the uncomfortable sensations as your bronchial tubes begin to narrow and your muscles around them start to tighten. A sticky mucus known as phlegm begins to produce and increase within your bronchial tubes and you begin to wheeze, cough and struggle to breathe.

Get My Free Ebook


Post a comment