Pharmaceutical Formulations by Medico Remedies Pvt. Ltd, Mumbai

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Transcript of Pharmaceutical Formulations by Medico Remedies Pvt. Ltd, Mumbai

Manufacturers & Exporters of Pharmaceutical Formulations

1. Introduction

2. Organogram

3. Our Quality Policy

4. Plot #9 – General Products: Floor Plans

5. Brief Description of Departments: General

6. Plot #8 – β-lactam Products: Floor Plans

7. Brief Description of Departments: β-lactam

8. Air Handling Systems

9. DM Water Plant

10. Effluent Treatment Plant

• Established in 1995 under the able guidance of Mr.HareshMehta (B.Pharm)

• WHO-GMP State of art facility

• ISO 9001:2008 Certified & Government recognized Star Export House

• 2 Separate units: General & β-Lactam (Penicillin & Cephlosporins)

• Well trained & competent technical staff

• Always growing & upgrading facility

• Export to over 34 countries

Medico Remedies is committed to consistently provide quality products and services in order to meet the customer’s satisfaction.

We achieve this by:

Continuously thriving to produce better than best.

Complying with the requirements of National and International regulatory agencies.

Practicing continuous improvement of our Quality Management System with Continual Training and Collective Wisdom.

Following cGMP standards and Safety requirements.

Maintaining eco-friendly environment.

• In this plant we manufacture Tablets, Capsules & Dry Syrups

• Maintained a unilateral flow of material through the manufacturing process

• Dedicated gowning & a separate material entry for all the crucial manufacturing areas

• Separate RM Store for APIs & excipients• Well equipped Quality Control department• 4 Compression machines, 4 Coating pans, 1

Semi-automatic Capsules Filling m/c, Dry Syrup m/c & 7 Primary Packaging m/c

• Total of 19 AHUs & 4 FDVs to ensure that the required temperature and humidity conditions are met

• Unique container loading system via a 100 feet conveyor

• Consists of Sampling Area, RM Quarantine, Approved APIs Store, Excipients Store & Dispensing Area

• Separate approved stores for APIs & Excipients

• Separation of under test & approved areas using Orange & Green chains

• Department consists of Rapid Mixer Granulator, Multimill, Sifter, Paste Vessel, Fluid Bed Dryer & an Octagonal Blender

• Dedicated gowning & separate material entry

• Department consists of 4 Compression machines & Dust extractors

• Dedicated gowning & separate material entry

• Department consists of 4 Coating Pans & Solution preparation equipments including Homogeniser & a Colloidal Mill

• Dedicated gowning & separate material entry

• Department consists of Semi-automatic Capsules filing SA-9 m/c, Dust extractors & Polishing m/c

• Dedicated gowning & separate material entry

• Equipped with many sophisticated instruments & well trained staff

• Common lab for both plants

• Completely separate entry to the plant

• Plant is divided into 2 Separate segments: namely Penicillins & Cephalosporins

• Each segment has its own Independent entry for man & material, as well as it own Independent air & water systems

• In the Penicillin segment, we manufacture Capsules & Dry Syrups

• In the Cephalosporin segment, we manufacture Tablets, Capsules & Dry Syrups

• Ground floor is a common store for Excipients & Packaging material

• Total of 24 AHUs & 3 FDVs to ensure that the required temperature and humidity conditions are met

• Department consists of Semi-automatic Capsules filing CAPFILL-2L+30 m/c & Polishing m/c

• Dedicated gowning & separate material entry

• Department consists of High speed Semi-automatic Powder filing & Labelling m/c.

AIR HANDLING SYSTEMS• Total of 19 AHUs & 4 FDVs in General Formulations Plant

• Total of 24 AHUs & 3 FDVs in β-Lactam Plant

• All AHUs designed with the base of Class-D at rest or Class-100,000at rest or ISO Class 8

• Minimum ACPH is 20

• Typical design of AHU consists of a Pre-filter, Refrigerating coil & Fine filter followed by Hepa filter in the terminal

AIR HANDLING SYSTEMS

DM WATER PLANT• Hard water is first passed

through the RO Plant

• Following that, it passes through the Cation, Anion, Mixed Bed & UV Chamber to remove all impurities

• Then it is passed through 3 independent Storage tanks through Non-return valves

• Independent storage & loop lines for General, Penicillin & Cephalosporin segments

• End points have diaphragm Valves to ensure continuous circulation

DM WATER PLANT

DM WATER PLANT

EFFLUENT TREATMENT PLANT

• At Medico, we treat the environment as top priority

• Zero discharge from the manufacturing process

• Discharge is only from domestic uses & from cleaning of equipments

• The ETP consists of Primary, Secondary & Tertiary stages to ensure clean & safe discharge

• Discharge is used for gardening purpose

EFFLUENT TREATMENT PLANT

EFFLUENT TREATMENT PLANT