SMALL VOLUME PARENTERAL (SVP)

[CODE NO.3988]

Brief Introduction to SVPs

The term ‘parenteral’ refers to injectable route of administration. It is actually derived from Greek words ‘Para’ which means ‘Outside’ and ‘Enteron’ which means ‘Intestine’. In other words, the word ‘parenteral’ refers to a route of administration other than the alimentary canal. The usual routes include the sub-cutaneous, intra-muscular, intra venous and SVP as well as LVP. It is an injection that is packaged in containers (or vials, cartridges, syringes, bottles, ampoules) labeled as containing 100 ml or less. As per the USP 24/NF 19, the definition of small volume parenteral is “Those preparations intended for injection through the skin or other external boundary tissue, rather than the alimentary canal – so that the active substances are administered using gravity or force directly into the blood vessel, organ, tissue or lesion”.

Details of Kinds of SVPs

The main kinds of SVPs are described below:

1. AMPOULES

These refer to sealed glass containers with an elongated neck that must be broken off. For easy breaking, most of the ampoules are weakened around the neck. These usually have a colored band around the neck.

Usually, to draw the contents of an ampule into a syringe, a 5 micron filter needle should be used. This is because there is a possibility that glass particles may have fallen inside the ampule when the top was snapped off. At times, it is advisable to wrap a small piece of gauze or alcohol wipe around the top of the ampule before breaking it.

2. VIALS

Various additives and drugs are packaged in vials either as liquids or lyophilized powders. There are usually sealed with a rubber stop and are made of glass or plastic. Usually, a needle is used to add or withdraw the contents.

Before withdrawal of contents, usually, equal volume of air is injected into the vial to pressurize it and assist in content withdrawal.

3. DRY POWDERS

These refer to freeze-dried or lyophilized formulations that must be reconstituted with some suitable solvent to make a liquid formulation. Drugs which are usually not stable in liquid form are put in powder form for use.

4. PREFILLED SYRINGES

These refer to syringes which are prefilled with drug solution. These consist of two kinds: cartridge type package and needle unit. Once the needle of the syringe is used, they are discarded. However, the holder is put to use again with a new unit.

Other Related Details of SVPs

Parenteral injections could include various products such as pharmaceutical products, biological products, biotechnology products, genetically engineered products, allergenic extracts, liposome and lipid products, radiopharmaceutical products, and others. The types of preparations could be drug injection, drug injectable emulsion, drug injectable suspension and others.

The containers usually used for parenteral packaging are glass, plastic and rubber. Parenterals are usually processed well before being put to use. These steps include: cleaning of containers, collection of materials, preparation of parenteral products, filtration, filling preparation in containers, sealing containers, sterilization, evaluation of parenteral preparation, labeling and packaging.

COST ESTIMATION

Plant Capacity : 120000 Nos

Land & Building (8000 sq.mt.) : Rs. 5.89 Cr

Plant & Machinery : Rs. 30.00 Cr

Working Capital for 2 Month : Rs. 3.26 Cr

Total Capital Investment : Rs. 39.77 Cr

Rate of Return : 24%

Break Even Point : 58%

INTRODUCTION

HOW INTRAVENOUS FLUIDS ARE CREATED

CLASSIFICATION OF SVP

PARENTERAL DRUGS

RESPULES

NEBULISING RESPULES FOR INHALATION

STERILE WATER FOR INJECTION OR WATER FOR RECONSTITUTION

OF DRY SYRUP

SVP AND DILUENTS

SVP & DILUENTS

AMPULES

VIALS

SMALL VOLUME PARENTERAL SOLUTION

PROPERTIES

TABLE 1. PHYSICAL PROPERTIES OF D-GLUCOSE

TABLE 2. SOLUBILITY OF DEXTROSE IN WATER

SOURCE OF MACHINES TECHNOLOGY

MARKET OVERVIEW OF PARENTERALS

GEOGRAPHICAL SEGMENTATION OF THE INTRAVENOUS SOLUTIONS

MARKET

COMPETITIVE LANDSCAPE AND KEY VENDORS

KEY VENDORS IN THIS MARKET ARE -

GROWTH DRIVERS, CHALLENGES, AND UPCOMING TRENDS: HOME TREATMENT

PRESENT MANUFACTURERS OF SVP

SOME GENERAL INTRAVENOUS FLUIDS

SPECIFICATION OF INDIAN PHARMACOPEIA ON I.V FLUIDS DEXTRAN 40 INJECTION

DEXTRAN 110 INJECTIONS

B.I.S. SPECIFICATIONS FOR PLASTIC I.V. BOTTLES

SODIUM CHLORIDE AND DEXTROSE INJECTION

IDENTIFICATION:-

ASSAY:

REQUIREMENTS OF RAW MATERIALS AND SPECIFICATIONS

WATER FOR INJECTION

HDPE PHARMA GRADE LAMINATE/ PLASTIC ROLL

LABELING

IDENTIFICATION

HEAVY METALS

BASIS OF BFS TECHNOLOGY

BLOW FILL SEAL (BFS) AND FORM FILL SEAL (FFS) TECHNOLOGY

CONCEPT OF BFS

FORMULATION ASPECT OF SVP {SMALL VOLUME PARENTERALS}

FORMULATION ASPECTS:

THERAPEUTIC AGENTS.

VEHICLES.

ADDED SUBSTANCES (ADDITIVES)

1) ANTIMICROBIALS.

2) ANTI OXIDANTS.

3) BUFFERS.

4) BULKING AGENTS.

5) CHELATING AGENTS.

6) PROTECTANTS.

7) SOLUBILIZING AGENTS.

8) TONICITY ADJUSTING AGENTS.

9) SURFACTANTS.

VEHICLES:

WATER FOR INJECTION (WFI):

STERILIZED WATER FOR INJECTION (SWFI):

BACTERIOSTATIC WATER FOR INJECTION (BWFI):

PRETREATMENT OF WATER FOR INJECTION

REVERSE OSMOSIS (RO):

DISTILLATION:

TERMINAL STERILIZATION:

BLOW FILL SEAL (BFS):

MANUFACTURING PROCESS OF SMALL VOLUME PARENTERALS {SVP}

FORM-FILL-SEAL TECHNOLOGY OR BLOW, FILL-SEAL TECHNOLOGY

FILTRATION (MEMBRANE):-

STERILIZATION (AUTOCLAVING):-

STERILIZATION (BY MOIST HEAT):-

COMPLETION/FINALISATION OF STERILE PRODUCTS:-

PRODUCT CONTAINERS AND CLOSURES:-

PROCESS FLOW DIAGRAM FOR PARENTERALS

COMPARISION OF SVP AND LVP

FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS

SWOT ANALYSIS

FORM FILL SEAL TECHNOLOGY

1. FORM-FILL-SEAL TECHNOLOGY:-

1.5 FILTRATION (MEMBRANE):-

LIST OF MACHINERY IV BAG PRODUCTION FORM FILL AND SEAL MACHINE

1. WATER PURIFYING

2. DISTILLATION

3. SOLUTION FILLING

4. STERILIZATION

5. PACKING

A TYPICAL FFS PROCESS WORKS AS FOLLOWS.

SUPPLIERS OF RAW MATERIALS

SUPPLIERS OF POTASSIUM PERMANGANATE

SUPPLIERS OF SODIUM CHLORIDE (I.P. GRADE)

SUPPLIERS OF DEXTROSE

ADDRESSES OF PLANT & MACHINERY SUPPLIERS (IMPORTED)

SUPPLIERS OF PLANT AND MACHINERY (INDIAN)

SUPPLIERS OF STERILIZING EQUIPMENTS

SUPPLIERS OF PM METER

SUPPLIERS OF LABELING MACHINES

SUPPLIERS OF TANKS

SUPPLIERS OF BOILER

SUPPLIERS OF FILTER PRESS

SUPPLIERS OF LABORATORY EQUIPMENTS

SUPPLIERS OF MIXER

EMPTY IV BAG MANUFACTURER AND SUPPLIER IN INDIA

CONSULTANT FOR SVP

SUPPLIERS OF COMPLETE PLANT AND MACHINERY

CONSULTANT OF TURNKEY PROJECT SUPPLIER OF THE PLANT

AND MACHINERY

CLEAN ROOM SUPPLIERS

MACHINERY CATALOG

APPENDIX – A:

1. COST OF PLANT ECONOMICS

2. LAND & BUILDING

3. PLANT AND MACHINERY

4. FIXED CAPITAL INVESTMENT

5. RAW MATERIAL

6. SALARY AND WAGES

7. UTILITIES AND OVERHEADS

8. TOTAL WORKING CAPITAL

9. COST OF PRODUCTION

10. PROFITABILITY ANALYSIS

11. BREAK EVEN POINT

12. RESOURCES OF FINANCE

13. INTEREST CHART

14. DEPRECIATION CHART

15. CASH FLOW STATEMENT

16. PROJECTED BALANCE SHEET

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