Manufacturing Equipment Risk Assessment

1.0 INTRODUCTION

The “Fluid Bed Dryer” is intended to create a fluidal turbulence in a granulated or powdery wet product by means of hot air (or dehumidified air) flowing in an upward direction & to dry the same to the final required degree in a careful manner with assurance of uniform drying and product safety.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment “Fluid Bed Dryer” installed in the Granulation area, in line with the guidance of the Risk Management manual of and ICH Q9

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment “Fluid Bed Dryer” and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

The Bin Blender is intended for mixing of material. Process container, such as a bin (IBC), are taken into the base of blending machine and adjoined with the mounting device. The material (mixture of pre-lubricant, lubricant and dry granules) loaded bin are rotated to achieve the final product uniformity.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment “Bin Blender” installed in the Blending area with the guidance of the Risk Management manual of and ICH Q9

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment “Bin Blender” and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

The Tablet Compression Machine is intended to compression of granules or powder for formation of Tablet. The machine is to be charged with the granulation mixture from container by means of a lifting column or Hopper or PTS. The Tablets are to be transported from the Compression machine, via a vertical tablet de-duster and a metal check detector, into the collection bins.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment “Tablet Compression Machine” installed in the Compression area with the guidance of the Risk Management manual of and ICH Q9

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment “Tablet Compression Machine” and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

The Tablet Coating Machine is intended film coating (solvent / aqueous based) of tablets. The tablets for coating shall be charged from the tablet drums (HDPE) / IBC into the coating machine by means of a lifting positing device. The discharging also must be undertaken in tablet drums (HDPE) / IBC via a discharge chute.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment “Tablet Coating Machine” installed in the Coating area with the guidance of the Risk Management manual of and ICH Q9

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment “Tablet Coating Machine” and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

The Capsule Filling Machine is intended to filling of granules or powder or pallets in the empty hard gelatine capsules. The machine is to be charged with the material from container by means of a lifting column or Hopper or PTS. The Capsules are to be transported from the Capsule filling machine , via a horizontal polishing, empty capsule sorter and a metal check detector, into the collection bins.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment “Capsule Filling Machine” installed in the Capsule filling area with the guidance of the Risk Management manual of and ICH Q9

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment “Capsule Filling Machine” and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

The Roller compactor forces fine powders between two counter rotating rolls and presses the material into a solid compact or sheet, so called flakes. Finally, these flakes are reduced in size to the desired size.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment’s, Roller Compactor, Rotray Sieve Dry, Product Transfer System installed in the Dry Granulation Area with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment installed in Dry Granulation are and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

Blister packing machine is used for packing of tablet & capsules. The blister packing machine is charged with tablets or capsules from drums by means of a lifting device. In blister pack operation, PVC / PVDC / aluminium base film web is drawn off from a reel and fed into the blister forming unit where blisters are continuously formed. The web is then led towards the sealing unit over a guide track.

On the guide track, the product is filled into the blisters by suitable automatic filling unit before the web enters the sealing unit. PVC / PVDC / aluminium foil / aclar is drawn off from a separate reel and is fed to the sealing unit where it is sealed with the base web, thus enclosing the product hermetically.

The filled and sealed web is then fed by an indexing mechanism into the pack punch unit where the packs are separated from the web. The web trim is sheared off to allow collection.

The blister packs are online checked for in process control parameters e.g. weight, empty, broken, print quality, color change, hair etc.

Blisters are transferred to packaging. A cartoning machine picks a single piece from stack of folded carton and erects it, fills with a product or bag of products or number of products horizontally through an open end and closes by tucking the end flaps of the carton or applying glue or adhesive. The product is pushed in the carton by compressed air.

Packed cartons are transferred for further packing in shipper boxes and palletizer. Cartons are packed in shipping boxes by secondary cartoning machine.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the equipment’s, Blister Packaging Machine, Cartoning Machine Labelling, Check Weigher Packaging Machine installed in the Primary & Secondary Packaging Area with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of equipment’s  installed in Primary & Secondary Packaging Area and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

For Complete Risk Assessment of PRIMARY & SECONDARY PACKAGING  Machine- Click on Read more, Subscribe and Download 

1.0 INTRODUCTION

The Tablet Inspection Machine is used for inspection of dirt, scratches, blurred prints, any other cosmetic damages to Tablets and Capsules.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Automatic Tablets Inspection Machine installed in the Inspection Area with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of the Automatic Tablets Inspection Machine installed in Inspection area and identify its failure mode.

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

This sterile filling machine is intended for use in bio specialty to fill pre-washed, pre-sterilized ampoules. The filling line consists of:

• Ampoule filling
• Ampule sealing
• Ampoule inspection

The pre sterilized pre washed quality ampoules of specified size are unwrapped and placed on conveyer for transferring towards the liquid filling under controlled atmosphere.

Filled ampoules automatically go for in-line sealing. There an appropriate control for filled volume check of empty and filled ampoules. Then sealed ampoules transferred towards ampoule inspection line.

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Ampoule Filling Machine with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Ampoule Filling Machine and identify its failure mode

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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1.0 INTRODUCTION

Cold storage units will be used to store temperature sensitive raw materials and products at their required temperature range: -

• Cold Storage (-21 deg °C)
• Cold Storage Unit (2-8 deg °C)

2.0 PURPOSE

Prepose of this risk assessment is to assess the risk associated with the Cold Storage with the guidance of the Risk Management manual of and ICH Q9.

3.0 SCOPE

This QRM document is applicable to the design, installation, operation, performance and safety of Cold Storage and identify its failure mode

10.0 RISK MANAGEMENT TOOLS

       FMEA-Qualitative Risk Management

10.1 Risk Identification

Identification of possible risk and damage to critical components, functions and processes.

10.2 Risk Analysis

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those components, functions and processes fail.

10.2.1 Probability Of Occurrence (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at some time) or low (unlikely to occur in most circumstances).

10.2.2 Severity (S)

Severity is the measurement of the possible consequences of a hazard.

The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to patients), medium (significant non-compliance with GMP or impact on patients) or low (minor infringement of GMP and no impact on patients).

10.2.3 Probability Of Detection (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.

The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection Low), medium (may be detected at some time – detection Medium) or low (will probably be detected – detection High).

10.3 Risk Evaluation

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O), Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the following table:

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