Steps are involved in the processing of parental preparations

Q. Define the term ‘parenteral products’. Describe in brief various steep involved in processing of parenteral preparation. 2075-02(IOM)

Ans:

parenteral products

Parenteral products/preparations are the sterile solutions or suspensions of drugs in aqueous or oily vehicles meant for introduction into the body by means of an injection under or through one or more layer of skin or mucous membrane.

-          They are sterile free from all type of living microorganisms and microbial products such as toxin, pyrogens etc.

-          Also be isotonic with body fluids.

 Following  steps are involved in the processing of parental preparations

1 cleaning of containers, closures and equipments:-

 All the containers, closures and equipments which are required during the preparation of parental products are thoroughly cleaned with detergent and washing is done with tap water , followed by clean distilled water and finally rinsed with water for injection. Rubber closures are washed with hot solution of 0.5 % sodium pyrophosphate in water  . The closures are then  removed from the solution, washed with water followed by rinsing with filtered water for injection .on a small scale washing is done manually but on a large scale automatic washing  machines are used .

2 collection of materials;-

 The various ingredients of the formulation of parental preparations are weighed and collected in the preparation room.  the raw materials required in the preparation of parenteral products should be pure.  water for injection free from pyrogens and microorganisms are used in preparation of parenteral products.

3 preparation of parenteral product;-

the pharmacist should decide the order of mixing and exact method of preparation to be followed before preparing the parenteral products. The parenteral preparation must be prepared under strict aseptic conditions. The ingredients are accurately weighed separately and dissolved in the vehicle as per method of preparation  to be followed.

4 filtration :-

 the parenteral Solutions so formed is passed through bacteria proof filter ,such as ,filter candle, seitz filter, membrane filter, and sintered glass filters. the primary objective of filtration is to clarify the solution by removing foreign particles .if the parenteral preparations  are required to be sterilized by means of bacteria proof filters, filtration should be done under  strict aceptic condition to avoid contamination of filtered solution, before it is finally transferred into final container and sealed.

5 filling the preparation in final containers;-

The filtered product is filled into final container such as, ampoules, vials and transfusion bottles, which are previously cleaned and dried. ampoules are used for feeling single dose  whereas,  vials are used for filling multidoses. bottles are meant for filling transfusion fluids. On small scale feeling is done manually by using hypodermic syringe and needle. on the large scale feeling is done by automatic filling machine.

The sterile Powders are filled into containers by individual weighing or by using automatic or semi automatic devices. The filling operation is carried out under Strict aseptic precautions.

During the filling of ampoules, the care should be taken that the solution should be filled below the neck of ampoules and the solution should not touch the neck of ampoules.  this will prevent the cracking and stanining of the neck of ampoules at the time of Sealing.

6 Sealing the containers:-

Sealing should be done immediately after filling. Ampoules are sealed manually on a small scale by rotating the neck of the ampoule in the flame of Bunsen burner but on a large scale ampoule sealing machine is used in which tip of ampoule is used to fused to seal it. The vials and transfusion bottles are sealed by closing its opening with rubber closures. The rubber closures are held in place by crimping the aluminium caps which is done manually or by mechanical means.

7 Sterilisation:-

The parental preparations should be immediately sterilized after sealing in its final containers. The sterilization is done by any one of the methods of sterilization which depends on the nature of Medicaments present in the parenteral preparations.

For thermostable medicament, the parenteral products are sterilised either by autoclaving at the temperature of 115°C to 116°C for 30 minutes or 121 degree centigrade for 20 minutes or in hot air oven at 160 degree centigrade for 2 hours. The thermolabile preparations are sterilised by filtration through a suitable bacteria proof filters. parenteral   preparations which are sterilised by filtration method may contain a suitable bacteriostatic agent to prevent the growth of microorganisms. When the solutions are used for intravenous or intrathecal injection in doses exceeding 15 ml, the bacteriostatic agent should not be used. the sterilised product is filled into the final containers and sealed. the process of filtration ,filling and sealing are done under aseptic conditions.

8 Evalution of parenteral preparations:-

 The finished parenteral products are subjected to the following test ,in order to maintain quality control

a) Sterility test

b) clarity test

c) Leakage test

d) Pyrogen test

e) Assay

9 Labelling and packaging:-

 After evaluation of the parenteral preparation, the ampoules ,vials and transfusion bottles are properly labelled and packed. The label should state:-

a) Name of the preparation

b) Quantity of the preparation

C) Mfg.Lic .no.

D) Batch no.

E) Date of manufacture

F) Date of expiry

G) Storage condition

H) Retail price

I) Manufacturer's address