Small Volume Parenteral

Premises, Equipment & Finishing of sterile products as per WHO TRS 961-Annex 6  It is highly recommended that all premises are designed in a way that minimizes the unnecessary entry of supervisory or control personnel. Specifically, Grade A and B areas should be constructed in a manner that allows for …

PERSONNEL TRAINING, QUALIFICATION, MONITORING AS PER USFDA GUIDELINE Personnel Training A well-designed, maintained, and operated aseptic process minimizes personnel intervention. As operator activities increase in an aseptic processing operation, the risk to finished product sterility also increases. To ensure the maintenance of product sterility, operators involved in aseptic activities must …

Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, …

VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized …

Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests …

Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least …

Operation, cleaning & calibration of pH meter 1.0       PURPOSE: To lay down the procedure for operation & calibration of pH meter. 2.0.      SCOPE :                                  This SOP shall be applicable for operation & calibration of pH meter of SVP manufacturing facility Equipment Name      Make &  Model No. Equipment ID pH …

CLEANING, OPERATION, MONITORING & PRECAUTIONS OF MANUAL VISUAL INSPECTION TABLE & PROCESS FOR MANUAL INSPECTION OF SVP CONTAINERS.  1.0     PURPOSE To lay down the procedure for cleaning, operation, monitoring & precautions of visual Inspection table & process for manual visual inspection of filled & sealed SVP containers. 2.0     SCOPE                                                                                                             …

Cleanroom behavior & personal hygiene 1.0      PURPOSE: To describe the procedure for personal hygiene & behavioral approach during clean room operation. 2.0.     SCOPE :                                   This SOP will be applicable for behavioral approach & personal hygiene for all the Staff, operators & workers of clean area of SVP …

Clean area footwear cleaning & sanitization 1.0  PURPOSE: To lay down the procedure for clean area foot ware cleaning & sanitization. 2.0     SCOPE :                                   This SOP is applicable for foot ware cleaning & sanitization for clean area of SVP section  3.0       REFERENCE(S) & ATTACHMENTS: 3.1       References 3.1.1    In-House …

Entry & Exit procedure for Clean Area Filling Room 1.0     PURPOSE: To provide the written procedure for entry & exit for clean area Filing room. 2.0.     SCOPE :                                   This SOP will be applicable for authorized staff & visitor’s movement in clean area   filling of SVP section. 3.0       REFERENCE(S) …

Charging of plastic granules PURPOSE To lay down the procedure of charging of plastic granules in FFS machine. 2.0      SCOPE                                   This SOP is applicable for charging of plastic granules in  FFS machine  at SVP section  3.0       REFERENCE(S) & ATTACHMENTS 3.1       References 3.1.1    In-House 3.2       Attachments 3.2.1    Attachment: I  Granule …

Operation & Calibration of Conductivity meter 1.0 PURPOSE: To lay down the procedure for operation & calibration of conductivity meter. 2.0      SCOPE :                                   2.1        This SOP is applicable for production department (SVP) for Operation and calibration of Conductivity meter. Make                                                 Modal Eutech                                               CON 700  3.0       REFERENCE(S) & ATTACHMENTS: …

BATCH PREPARATION OF SVP PRODUCTS 1.0     PURPOSE           To establish the written procedure for batch preparation of SVP products. 2.0     SCOPE This SOP shall be applicable for batch preparation of SVP products at SVP section 3.0     REFERENCE(S) & ATTACHMENT(S)          3.1           REFERENCE(S) 3.1.1.    USP <797> Pharmaceutical compounding sterile preparation.             …

Area cleaning and sanitization PURPOSE : To define procedure for cleaning of production and other adjacent area. SCOPE : This SOP applicable for cleaning and sanitization of furniture, fixture, floor, walls, trolley etc. REFERENCE(S) & ATTACHMENTS : 3.1       References In House 3.2       Attachments 3.8.1   Attachment -I   : Daily cleaning record …