PURPOSE:  To avoid contamination with microorganisms during manufacturing of sterile products, careful attention to the special handling requirements, aseptic techniques and observance of good manufacturing practices must be maintained. Hence the aseptic filling process needs to be validated to ensure that our aseptic manufacturing techniques are satisfactory.

 RESPONSIBILITY :

                                    1. Q. A. In-charge.

                                    2. Production Manager

PROCEDURE

1. Prepare soybean casein digest media in water for injection sufficient to fill minimum 3000 units.

2. Sterilize media in autoclave at equivalent time of F0 = 15 mm. at 121 °C. Check the pH of media. The pH of media must be 7.3 ± 0.2 after autoclaving.

3. Prepare 100 ml soybean casein digest media in water for injection in 250 ml. flask and sterilize in autoclave at equivalent time of F0 15 mm. at 121 °C. This media will be used for testing filtered sterile nitrogen as mentioned in (B).

4. Fill media aseptically performing all procedures identical to regular product.

5. Do Not use sterile nitrogen for pre and post filling during media filling.

6. Equipment parts that come in contact with media must be both sterile and completely free of any substance that could inhibit, growth of microorganisms. In case of media fills during ongoing operations at the end of the day’s activity, a fresh filling unit set up should be used for media filling.

7. Each person who normally participates in aseptic filling of products should participate at least annually in an aseptic fill validation

(Review date on or  before 12 months from date of authorization)