Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging

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Vial Washing Machine: Streamlining Sterile Pharmaceutical Packaging

In the pharmaceutical industry, maintaining the integrity and cleanliness of packaging materials is crucial for ensuring the safety and efficacy of drugs. Vial washing machines play a vital role in the production of sterile pharmaceuticals by efficiently cleaning and sanitizing vials before they are filled with medications. These machines employ advanced technology and processes to remove contaminants, such as particles, microorganisms, and residues, ensuring the highest standards of quality and compliance. In this blog post, we will explore the concept of vial washing machines, their importance, key features, validation considerations, and best practices for optimal performance in the pharmaceutical manufacturing process.

I. Understanding Vial Washing Machines

A. Definition and Purpose:

  1. Definition: Explain vial washing machines as automated equipment designed to clean and sanitize vials used in pharmaceutical packaging.
  2. Purpose of Vial Washing Machines: Discuss how these machines remove contaminants, such as particles, microorganisms, and residues, ensuring vials are clean and ready for sterile drug filling.

B. Types of Vial Washing Machines:

  1. Rotary Vial Washing Machines: Discuss the operation and features of rotary vial washing machines, which utilize a rotating motion to clean vials in a continuous manner.
  2. Linear Vial Washing Machines: Explain the operation and features of linear vial washing machines, which clean vials in a linear or linear-indexing motion.

C. Key Features and Components:

  1. Washing Chambers: Describe the washing chambers in vial washing machines, which are equipped with nozzles or jets that spray cleaning solutions and rinse water onto the vials.
  2. Cleaning Mechanisms: Explain the different cleaning mechanisms employed by vial washing machines, such as air jet cleaning, water jet cleaning, or brushing, to remove contaminants from vials.
  3. Drying Systems: Discuss the drying systems integrated into vial washing machines, such as hot air or compressed air, to ensure vials are dry before further processing.

II. Importance of Vial Washing Machines in Pharmaceutical Packaging

A. Compliance with Regulatory Standards:

  1. Good Manufacturing Practices (GMP): Explain how vial washing machines are crucial for complying with GMP regulations, which require thorough cleaning and validation of packaging materials in the pharmaceutical industry.
  2. Pharmacopoeial Guidelines: Highlight relevant pharmacopoeial guidelines, such as USP <1236>, EP 5.5, or JP 16, that provide specific requirements for vial washing processes.

B. Contamination Control and Product Safety:

  1. Particle Removal: Discuss how vial washing machines effectively remove particles, including visible and non-visible contaminants, to ensure product safety and reduce the risk of particulate contamination.
  2. Microbial Decontamination: Explain the importance of vial washing machines in eliminating or reducing microbial contamination on vials, preventing microbial growth and product spoilage.

C. Process Efficiency and Cost Savings:

  1. Increased Throughput: Discuss how vial washing machines enable high-speed, automated cleaning processes, allowing for increased production throughput and efficiency.
  2. Water and Energy Conservation: Highlight the sustainability benefits of vial washing machines, as they are designed to optimize water and energy consumption, leading to cost savings and reduced environmental impact.

III. Validation and Qualification of Vial Washing Machines A. Installation Qualification (IQ) and Operational Qualification (OQ):

  1. IQ Activities: Discuss the installation qualification activities, including verification of equipment installation, utilities, and environmental requirements.
  2. OQ Activities: Explain the operational qualification activities, such as functional testing, performance verification, and process parameter optimization, to ensure the machine operates within predefined specifications.

B. Performance Qualification (PQ) and Process Validation:

  1. PQ Activities: Discuss the performance qualification activities, including testing the vial washing machine with actual vials and evaluating the cleaning effectiveness, cycle times, and process parameters.
  2. Process Validation: Explain the importance of process validation for vial washing machines, which involves demonstrating the consistency and repeatability of the cleaning process through statistical analysis and performance monitoring.

C. Cleaning Validation and Analytical Methods:

  1. Cleaning Validation Protocols: Discuss the development and execution of cleaning validation protocols to demonstrate that vial washing machines effectively remove residues and contaminants from vials.
  2. Analytical Methods: Explain the analytical methods used in cleaning validation, such as visual inspection, particle counting, total organic carbon (TOC) analysis, or microbial testing.

IV. Best Practices and Operational Considerations

A. Cleaning Process Optimization:

  1. Cleaning Agents and Parameters: Discuss the selection of appropriate cleaning agents, concentrations, temperatures, and contact times for efficient and effective vial cleaning.
  2. Water Quality: Highlight the importance of using high-quality water, such as purified water or water for injection (WFI), in the vial washing process to avoid introducing contaminants.

B. Preventive Maintenance and Calibration:

  1. Maintenance Schedule: Discuss the significance of implementing a preventive maintenance schedule to ensure the proper functioning of vial washing machines and minimize downtime.
  2. Calibration and Performance Checks: Explain the importance of regular calibration and performance checks of critical parameters, such as water pressure, temperature, and drying air flow, to maintain consistent cleaning performance.

C. Personnel Training and Good Documentation Practices:

  1. Training Programs: Highlight the importance of comprehensive training programs for operators and maintenance personnel to ensure proper operation, maintenance, and troubleshooting of vial washing machines.
  2. Documentation Practices: Discuss the importance of maintaining accurate and up-to-date documentation, including standard operating procedures (SOPs), equipment logs, and cleaning validation records.

V. Conclusion

Vial washing machines are vital equipment in the pharmaceutical industry, ensuring the cleanliness and integrity of vials used in sterile drug packaging. These machines remove contaminants and residues, complying with regulatory standards, and contributing to product safety and quality. By understanding the importance of vial washing machines, their key features, validation considerations, and best practices for optimal performance, pharmaceutical manufacturers can streamline their packaging processes, enhance efficiency, and uphold the highest standards of cleanliness and compliance. Vial washing machines play a critical role in maintaining the integrity of pharmaceutical products, safeguarding patient health, and ensuring the success of the pharmaceutical industry as a whole.

VIAL WASHING MACHINE PQ PROTOCOL

TABLE OF CONTENTS

Description
Protocol approval
Overview
Purpose
Scope
Responsibilities and identification of execution team
Pre-Validation requirement
Equipment description
Validation procedure
Sampling plan and Acceptance criteria
Validation report
Validation approval
Observed deviation
List of attachment
Re-qualification Criteria

Protocol Approval

The signing of this approval page of protocol indicates agreement with the qualification approach described in this document. If any modification in the equipment qualification approach becomes necessary, a revision through change control shall be prepared, checked, and approved. This protocol cannot be executed unless approved by the following personnel.

Overview

To establish the methodology for the validation of vial washing machine, which is used for washing of different size glass vials of size 10 ml, 15 ml, 20 ml, 50 ml and 100 ml having eight Different washing stages includes treatment of Recirculating Purified water, Purified water, Water for injection and Compressed air.

Purpose

The purpose of this Protocol is to carry out validation of vial washing machine to:

  • Demonstrate that Vial Washing Machine shall perform washing of different sizes of vials which meets the desired acceptance criteria in a consistent manner when operated as per the standard operating procedure.
  • The validation shall be tested at extreme and optimum operation condition

Scope

The scope of this validation exercise is limited to the validation of vial washing machine located in production injection area.

RESPONSIBILITIES AND IDENTIFICATION OF EXECUTION TEAM 

Responsibilities: The group comprising of representatives from each of the following departments and they shall be responsible for the overall compliance with this protocol. 

Engineering & Utility : Arranging for execution of the document and providing facilities
Production : Participate and provide necessary support for the qualification.
Quality Control: For testing of the sample involved
Quality Assurance: Monitoring the qualification activities. Data compilation and review of the generated data.

Preparation of the Qualification report in consultation with the qualification team.

Authorization of the qualification report.

Identification of Executors: The personnel involved in the execution of this protocol shall be recorded Name, Designation, Signature, and Date.

Pre – Validation Requirements

Following chemical/equipment shall be required for the validation of Vial Washing Machine.

  • Sodium Chloride.
  • Activated Charcoal Powder
  • Bacterial endotoxin
  • Liquid Particle Counter
  • Weighing balance
  • 10 ml moulded glass vials USP type –I
  • 15 ml moulded glass vials USP type –I
  • 20 ml moulded glass vials USP type-1
  • 50 ml moulded glass vials USP type –I
  • 100 ml moulded glass vials USP type –1
  • System / Equipment Description
  • System/Equipment Details

The vial washing machine shall be used for washing of different sizes of glass vials from 10 to 100 ml in eight different washing stages which include treatment of Recirculating water purified water, purified water, water for injection, and compressed air.

Description:

  • Equipment Tag Number
  • Location : Washing And Sterilization Room
  • Name of the system/Equipment: Vial washing Machine
  • Manufacturer’s Name / Address :
  • Model
  • Dimensions
  • Width : 2220 mm
  • Height:1675 mm
  • Length:3840 mm

Design

Working Principle:

The Vial Washing Machine  is designed to wash vials of different sizes. Complete washing of vials will occur in eight different washing stages comprising of Re-circulated purified water, Purified Water, Water for Injection and Compressed Air.

The Vial Washing Machine  works on the principle of jet  washing of the individual vials in inverted position by a series of jets, 25 pockets are used for washing of 10, 15 and 20 ml vials. 12 Pockets are used for washing of 50 and 100 ml Vials.  The maximum rated capacity of the machine is 18000 vials per hour incase of 25 pockets, and 6000 vials per hour in case of 12 pockets. In feed lifter carries the vials in to the pockets & moving on a chain horizontal conveyor with vertical up spray nozzles, entering the vials co-axially and injected re circulated purified water, purified water, water for injection & compressed air at specified station

Brief Instrument Description

The Vial washing Machine comprises of following parts:

  • Vial Infeed zone
  • Vial washing zone
  • Outfeed zone
  • Outfeed conveyor
  • Pump, Tanks, Pipe fittings & Pressure gauges
  • Filter housing & Filter housing

Vial In feed Zone:-.

The process of washing begins with loading of vials on infeed platform and pushing manually to the conveyor. The conveyor carries the vials on the infeed lifter by the help of loosening device. The infeed lifter carries the vials into the pockets.

Vial Washing Zone:

The vials set up in to the pockets after feeding. The index channel of vials carries forward at a time. During each stoppage of this movement, nozzles manifold raises up and nozzles enters the mouth of each individual vials. A solenoid valve in the water and air lines is activated and a jet of air/water hits the inside of the vials to clean it. .An external cleaning station cycle is also provided. Standard washing cycle occurs as per following sequence:-

Washing Cycle
1st wash: Compressed Air  (Internal wash)
2nd wash: Recirculated purified water (External wash)
3rd wash: Recirculated purified water (Internal wash)
4th wash: Purified water (External wash)
5th wash: Purified water (Internal wash)
6th wash: WFI water (External wash)
7th wash: WFI water  (Internal wash)
8th wash: Compressed Air  (Internal wash)

Outfeed Zone:

After washing these washed vials are taken away from the pockets with support of vials guide plate and come out of the outfeed lifter. Outfeed lifter come down and the pusher pushes the vials on the outfeed platform and conveyor

Outfeed Conveyor:

The outfeed conveyor is chain linked with mesh conveyor made up of stainless steel 316 which conveys the washed vials from the unloading unit to the infeed of sterilizing tunnel. The speed of conveyor is controlled from the control panel of the machine

Validation Procedure:    

The following tests shall be carried out to establish the validation of Vial Washing Machine:

  • Chemical decontamination study (By spiking with Sodium chloride)
  • Particulate decontamination study (by spiking with Charcoal powder).
  • Endotoxin decontamination study (By spiking with Endotoxin).

Test Matrix

The following matrix shall be followed for the validation of vials washing machine:

Table-1

S. No. Vial Size No. of Trails Tests
Size (ml) Tubular / Moulded Sodium

Chloride

 Charcoal Powder Endotoxin
10 Moulded 3 √ √ √
15 Moulded 1 √ √ √
20 Moulded 1 √ √ √
50 Moulded 1 √ √ √
100 Moulded 3 √ √ √

 Table-2

S. No. Vial Size (ml) Volume of rinse fluid (WFI)
1. 10 ml 7 ml
2. 15 ml 10 ml
3. 20 ml 15 ml
4. 50 ml 30 ml
5. 100 ml 50 ml

Table-3

Vial spiked for each test

S. No. Vial Size No. of Trails No. of Vials spiked for test*
Size (ml) Tubular / Moulded Sodium

Chloride

 Charcoal Powder Endotoxin
1. 10 Moulded 3 3 x 25 3 x 25 3 x 25
2. 15 Moulded 1 25 25 10
3. 20 Moulded 1 25 25 10
4. 50 Moulded 1 12 12 10
5. 100 Moulded 3 3 x 12 3  x 12 3 x 10

* 2 vials as positive control for each test shall be spiked and preserved separate.

Chemical Decontamination Study

The following tests shall be carried out to establish the efficiency of vial washing machine to removed chemical matter.

Spiking of vials with Chemical (Sodium chloride)

Preparation of sodium chloride solution

Weigh 40 gm of sodium chloride & dissolve in purified water to make up the volume 200 ml.

Spiking of vials with chemical

Spiked the no. of vials as per the table 3 for test.

  • Dispense 1.0 ml of the sodium chloride solution to vial to be spiked.
  • Swirl the vial so that the solution is distributed throughout the vial.
  • Mark the vials with a permanent marker resistant to washing.
  • Dry the vials at 60°C till no water traces are observed in the vial.

Initial chemical concentration determination (Positive control)

Determine the initial chemical concentration in the vial as per the following procedure the initial concentration of NaCl solution shall be determined by quality control.

Chemical Matter decontamination study

Objective

The objective of this test is to determine that the vial washing machine is capable of removing chemicals matter, if present in the vials.

Test Requirements

  • Sodium chloride spiked vials

Test Procedure

The procedure for the chemical decontamination study is defined below

  • Load the In-feed belt to the Vial Washing machine with vials of one of the selected pack size.
  • Set up a vial washing machine as per procedure. Fix the Water Jet Heights, Machine Speed and Water Tanks Refill Time properly.
  • Switch “ON” The Vial Washing Machine and operate as per SOP No. PI-SP-006.
  • Allow the machine to run & place 25 vials of spiked & marked vials in between the other vials while machine is running as per conditions as defined.
  • Allow the spiked / challenge vials to go through washing cycle.
  • Collect the washed (spiked) vials after completion of washing cycle. Separate the marked vials
  • Transfer the collected vial to Q.C. laboratory for testing.
  • Fill the vials with filtered water as per the quantity defined in Table-2 and vortex the vials for 2-3 minutes.
  • Pool the sample and Perform the analysis for a spiked vial as defined in previous section.

Acceptance Criteria

Sodium chloride content in spiked and washed vial should not be more than 2 ppm.

Results

The result shall be recorded in Text Datasheet.

Particulate Matter decontamination study

Objective

The objective of this test is to determine that the machine is suitable to remove particulate matter from the spiked vials.

Test Requirements

  • Liquid Particle counter
  • Charcoal powder

Spiking of vials with charcoal

Preparation of charcoal solution (0.6 %)

Weigh 20 gm of charcoal & dissolve in purified water to make up the volume of 300 ml.

Spiking of vials with chemical

Spiked the no. of vials as per the table 3 for test.

  • Dispense 1.0 ml of the charcoal solution to vial to be spiked.
  • Swirl the vial so that the solution is distributed throughout the vial.
  • Mark the vials with permanent marker resistant to washing.
  • Dry the vials at 60°C till no water traces are observed in the vial.

Test Procedure

Following the procedure defined below for the particulate decontamination study

  • Load the In-feed belt to the Vial Washing machine with vials of one of the selected pack size.
  • Set up a vial washing machine as per procedure. Fix the Water Jet Heights, Machine Speed and Water Tanks Refill Time properly.
  • Switch “ON” The Vial Washing Machine and operate as per SOP No. PI-SP-006.
  • Allow the machine to run & place 25 vials of spiked & marked vials in between the other vials while machine is running.
  • Allow the spiked / challenge vials to go through washing cycle.
  • Collect the washed (spiked) vials after completion of washing cycle. Separate the marked vials & store them under LAF so as to avoid any contamination from environment.
  • Transfer the collected vial to IPQA area.
  • Fill the vials with filtered water (WFI) as per the quantity defined in Table-2 and vortex the vials for 2-3 minutes.
  • Pool the water sample and perform the analysis for a spiked vial also and use the same as positive control and filter water (WFI) as blank.
  • Calculate the particles count in the spiked washed vials be subtracting the particles of the water blank

Acceptance Criteria

LBPC: for ≥ 10µ: 6000/100 ml

for ≥ 25µ: 600/100 ml

Result: 

The result shall be recorded in text Data Sheet.

Endotoxin decontamination study

Spiking of vials with endotoxin

  • Spiked the no. of vials as per the table 3 for test.
  • Reconstitute Endotoxin Indicators vial containing 100,000 Endotoxin units with 10 ml Lal Reagent Water [LRW] to give the concentration of 10,000 EU/ml.
  • Vortex it for 20 to 25 minutes.
  • Transfer 0.1 ml of the content (1000 EU) in each vial to be spiked.
  • Swirl the vial gently so that solution is wets the entire inner surface area of the vial to be spiked.
  • Air dry the spiked vial at room temperature under LAF.

Recovery of Endotoxin from spiked vials (Positive control):

  • Add 4.0 ml LRW into the into the spiked containers (Assumed potency on the basis of 100% recovery = 1000 EU/ml.
  • Sonicate the container for 10-15 minutes
  • Dilute the reconstituted container as follows :
Dil. No. Dilution step Concentration Total dilution
1 0.1 mL of 1000 EU/mL + 3.9 mL of LRW 25 EU/mL 1 :40
2 0.1 mL of 25 EU/mL + 0.9 mL of LRW 2.5 EU/mL 1 :400
3 0.1 mL of 2.5 EU/mL + 0.9 mL of LRW 0.25 EU/mL 1 :4000
4 0.5 mL of 0.25 EU/mL + 0.5 mL of LRW 0.125 EU/mL 1 :8000
5 0.5 mL of 0.125 EU/mL + 0.5 mL of LRW 0.06 EU/mL 1 :16000
  • Perform the LAL Gel Clot test from dilution no. (3), (4) and (5).
  • Record the results.
  • Calculation

Calculate by following formula:

Recovery = Reciprocal of last dilution which was positive x lambda [l].

Endotoxin decontamination study

Objective

The objective of this test is to determine that the vial washing machine is capable of removing endotoxin load, if present in the vials.

Test Requirements

  • Endotoxin Kit
  • Endotoxin spiked vials

Test Procedure

Following the procedure defined below for the endotoxin decontamination study

  • Load the In-feed belt to the Vial Washing machine with vials of one of the selected pack size.
  • Set up a vial washing machine as per procedure. Fix the Water Jet Heights, Machine Speed and Water Tanks Refill Time properly.
  • Switch “ON” The Vial Washing Machine and operate as per SOP No. PI-SP-006.
  • Allow the machine to run & place 10 vials of spiked & marked vials in between the other vials while machine is running.
  • Allow the spiked / challenge vials to go through washing cycle.
  • Collect the washed (spiked) vials after completion of washing cycle. Separate the marked vials
  • Transfer the collected vial to laboratory for testing.
  • Determine the endotoxin content in the washed spiked containers.
  • Put 1 ml of LRW in washed vial to obtain 10 EU/ml and perform the test as per dilution given below:
Dil. No. Dilution step Conc Dilution
1 0.1 ml of 10 EU/mL + 3.9 mL of LRW 0.25 EU/mL 1 :40
2 0.5 mL of 0.25 EU/mL + 0.5 mL of LRW 0.125 EU/mL 1 :80
3 0.5 mL of 0.125 EU/mL + 0.5 mL of LRW 0.06 EU/mL 1 :160
  • Perform the LAL Gel Clot test from dilution no. (1), (2) and (3).
  • Calculation: Calculate the log reduction by following formula:
  • Log reduction in endotoxin = log of recovered endotoxin from spiked container
  • Log of recovered endotoxin from exposed containers.

Acceptance Criteria

A minimum log reduction of 2 log should be achieved.

Results

Results shall be recorded Test Datasheet.

Critical processing variable

Process variables: The validation shall be tested at extreme and optimum operation conditions as described below

S. No. Speed of machine

(10-20 ml vials)

       Parameters

 

 Values set

 
01 250 Vials/min

 

 compressed air blowing time 2.0 sec
Recirculating purified water wash time 2.0 sec
Purified water wash time 2.0 sec
Water for injection 2.0 sec
02

 

 275Vials/min

 

 

 Compressed air blowing time 2.5 sec
Recirculating purified water wash time 2.5 sec
Purified water wash time 2.5 sec
Water for injection 2.5 sec
03

 

 300Vials/min

 

 Compressed air blowing time 2.5 sec
Recirculating purified water wash time 2.5 sec
Purified water wash time 2.5 sec
Water for injection 2.5 sec

 

S. No Speed of machine

(50 & 100 ml vials)

       Parameters

 

 Values set

 
01 80 vials/min compressed air blowing time 4.5 sec
Recirculating purified water wash time 4.5 sec
Purified water wash time 4.5 sec
Water for injection 4.5 sec
02 120 vials /min

 

 

 

 compressed air blowing time 4.5 sec
Recirculating purified water wash time 4.5 sec
Purified water wash time 4.5 sec
Water for injection 4.5 sec
03 150 vials/min compressed air blowing time 4.5 sec
Recirculating purified water wash time 4.5 sec
Purified water wash time 4.5 sec
Water for injection 4.5 sec

Sampling Plan and Acceptance Criteria:

Stage 1: WFI quality

Sampling Criteria: Visual Check and LBPC

Sample quantity: Around 100 ml

Stage 2: Compressed air quality (Bubbling of compressed air in 100 ml water)

Sampling Criteria: Visual Check and LBPC

Sample quantity: Around 100 ml

Acceptance Criteria

  1. Shall be free of visible particles
  2. ≥10 µ =NMT 60/ml & ≥25 µ NMT 6/ml

Stage 3:  After Vial washing

Sample quantity: Sodium chloride spiked vials

Acceptance Criteria

Removal of chemical matter

  • 25 spiked vials for 10, 15 & 20 ml vials
  • 12 spiked vials for 50 & 100 ml vials

Acceptance Criteria: Less than 2 ppm

Stage 4:  After Vial washing

Sample quantity: Charcoal spiked vials

Acceptance Criteria

  1. Shall be free of visible particles
  2. ≥10 µ =NMT 60/ml & ≥25 µ NMT 6/ml

Stage: After Vial washing

Sample quantity: Bacterial Endotoxin spiked vials

Acceptance Criteria

Endotoxin decontamination study – Should show more than 2 log reduction

Validation Report

The validation report shall consist of a summary document, in narrative form, which shall briefly describe the activity performed along with the observations recorded in relevant exhibits.

This report shall also include the related documents and attachments/exhibit which were completed at the time of Validation activity.

Approval of Validation Report

The report shall be evaluated and proper references/conclusions/recommendations shall be recorded by quality assurance.

The validation report shall be evaluated and finally approved by quality assurance.

Test Data Sheet # 1

Chemical decontamination study

Date of trial
Trial No,
Test Parameter
Solenoid valve timer
Vial Type
The conductivity of Blank ions:

 

Vial type
10 ml moulded glass vials USP type –III
15 ml moulded glass vials USP type –I
100 ml moulded glass vials USP type –I

Phase I : At low speed with 10 ml, 15 ml & 100 ml glass vials

Phase II : At medium speed with 10 ml, 15 ml & 100 ml glass vials

Phase III : At high speed with 10 ml, 15 ml & 100 ml glass vials

Chemical/Reagent Used :Sodium Chloride

Acceptance criteria : The conductivity of washed vials should not be more than 1. 3µs/cm of WFI

Machine Speed (Vials/mins.)
Compressed Air Blowing Time (Seconds)
Re-circulating purified water wash time (Seconds)
Purified water wash time (Seconds)
Water For Injection Wash Time (Seconds)

Test Data Sheet # 2

Removal of Insoluble Matter

Date of trial
Trial No,
Test Parameter
Solenoid valve timer
Vial Type

 

Vial type:
10 ml moulded glass vials USP type –III
15 ml moulded glass vials USP type –I
100 ml moulded glass vials USP type –I

Phase I : At low speed with 10 ml, 15 ml & 100 ml glass vials

Phase II : At medium speed with 10 ml, 15 ml & 100 ml glass vials

Phase III : At high speed with 10 ml, 15 ml & 100 ml glass vials

Chemical/regent Used :Activated charcoal powder

Acceptance criteria :

Visible particles :The vials should be free from visible particles.

Sub visible particles :
>10 µ: Not more than 60 / ml
> 25 µ: Not more than 6 / ml

Parameters
Machine Speed (Vials / mins.)
Compressed Air Blowing Time (Seconds)
Re-circulating purified water wash time (Seconds)
Purified water wash time (Seconds)
Water For Injection Wash Time (Seconds)

     Vial Number Visible Particulate Matter
Black White Fibers
1

 

Container no. Sub Visible Particulate Matter Acceptance

(Yes /No)
³10 micron ³25 micron
1

Test Data Sheet # 3

Removal of Glass Fragments

 

Date of trial
Trial No,
Test Parameter
Solenoid valve timer
Vial Type
Vial type 10 ml moulded glass vials USP type –III
15 ml moulded glass vials USP type –I
100 ml moulded glass vials USP type –I
Phase I At low speed with 10 ml, 15 ml & 100 ml glass vials
Phase II At medium speed with 10 ml, 15 ml & 100 ml glass vials
Phase III At high speed with 10 ml, 15 ml & 100 ml glass vials
Chemical/regent Used Fine glass fragments
Acceptance criteria The vials should be free from the glass particles when observed visually

 

S. No. Parameters Values Set
01 Machine Speed (Vials / mins.)
02 Compressed Air Blowing Time (Seconds)
03 Re-circulating purified water wash time (Seconds)
04 Purified water wash time (Seconds)
05 Water For Injection Wash Time (Seconds)
Vials Number Glass fragments (Yes / No) Vials Number Glass fragments (Yes / No)
1 2

Results

Qualified Not qualified

Test Data Sheet # 4

Residual Water Determination in Washed Vials

Date of trial
Trial No,
Test Parameter
Solenoid valve timer
Vial Type
Vial type 10 ml moulded glass vials USP type –III
15 ml moulded glass vials USP type –I
100 ml moulded glass vials USP type –I
Phase I At low speed with 10 ml, 15 ml & 100 ml glass vials
Phase II At medium speed with 10 ml, 15 ml & 100 ml glass vials
Phase III At high speed with 10 ml, 15 ml & 100 ml glass vials
Chemical/regent Used Activated charcoal powder
Acceptance criteria The weight of residual water should not be more than
A. 0.4 g – For 10ml & 15ml Vials
B. 1.0g – For 100 ml vials.

 

S. No. Parameters Values Set
01 Machine Speed (Vials / mins.)
02 Compressed Air Blowing Time (Seconds)
03 Re-circulating purified water wash time (Seconds)
04 Purified water wash time (Seconds)
05 Water For Injection Wash Time (Seconds)

 

Vials Number Initial Weight in grams(A) Final Weight in grams(B) Weight of Residual Water in grams(B-A) Acceptance

(Yes / No)
1

Result : Pass /Fail

Test Data Sheet # 5

Insoluble Particulate Matter in WFI after filtration, before washing

 Acceptance criteria                     :

Visible particles                       : The vials should be free from visible particles

Sub visible particles                :   >10 µ: Not more than 60 / ml & > 25µ: Not more than 6 / ml

Container  identification Visible Particulate Matter
Black White Fibers
WFI      

Results

Qualified Not qualified

 

Container  identification Sub Visible Particulate Matter Acceptance

(Yes /No)
³10 micron ³25 micron
WFI      

Results

Qualified Not qualified

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