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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
When considering the development, documentation, and implementation of Commercial Sterility Processing within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Commercial sterility techniques have been used since the early 19th century to preserve foods. Early techniques involved sealing foods into glass bottles and boiling the bottles in water for extended time frames. By the mid-19th Century, tin-coated steel containers were being used in what would become one of the most prevalent food preservation techniques used throughout the world.
Commercial sterility techniques are perfect for preserving foods as they kill and deactivate micro-organisms and their spores through structured process controls involving the creation of an anaerobic environment and time and temperature treatments.
Microorganisms, many of which are harmful to humans, are also responsible for the spoilage of foods. Applying a suitable temperature to foods over a defined period breaks down proteins, which are essential components of living cells. This protein degradation kills vegetative bacteria, which is the easy part of the commercial sterility process. The challenge is to kill bacterial spores, which are more robust than vegetative bacteria. Bacterial spores are difficult to kill because they have thick protective walls which increase their resistance to heat, drying, freezing, chemicals, and radiation. The ‘kill step’ for bacterial spores widely defines the modern parameters for Commercial Sterility.
Modern Commercial Sterility techniques include retorting, static aseptic, and continuous flow applications:
The goal of all variants of Commercial Sterility is to produce foods that remain sterile whilst their packaging remains intact.
A D-value can be better explained as the specific time required at a specific temperature to kill, for example, 90% of bacterial spores, which is the same as reducing their number by one logarithm unit. In short; The D-value is a measure of heat resistance applied to a specified type of bacteria. It is important to consider that the D-value will be affected by, and is dependent on the species of bacterial spores involved.
The outcome of any heat sterilization process depends heavily on the following factors:
Commercial Sterility Processing relies on the application of one or more steps at which microorganisms are killed and their spores destroyed. When applying a sterilization procedure such as the application of heat, it is important to consider that not all bacterial spores are killed at the same time. A certain number of bacterial spores will be killed within any given period at a suitable heat, but not all of them.
This is where the most important factor of Commercial Sterility Processing comes to the forefront; the kill step is independent of the sterilization temperature; it is more reliant on time as a control mechanism.
The process through which time and temperature are used to kill bacteria is commonly known as Logarithmic Reduction. Because logarithmic bacterial reduction can reach zero, it is never possible to guarantee absolute sterility. In this context, the efficiency of sterilization is expressed by the number of decimal reductions in the count of bacterial spores. The D-value, or Decimal Reduction Time is commonly used to indicate the killing rate of bacterial spores.
In some Commercial Sterility processing applications, more than one temperature and time combination are applied to achieve the required product sterilization. This technique is increasingly utilized to maintain product quality aspects. In such instances, the required change in temperature is known as the Z-value. The Z-value is defined as the change in temperature required to alter the D-value by a factor of one logarithmic unit.
As absolute sterility is not achievable, sampling plans with nominated acceptable tolerances are commonly defined for displaying conformance with the method of Commercial Sterility Processing employed.
A common example of a sampling plan applied for Commercial Sterility Processing is to apply a maximum acceptable defect rate of 1 per 10000 samples. To determine the effectiveness of the Commercial Sterility Processing methods employed, and to ensure the number of maximum defects does not exceed the nominated target, sampling procedures are implemented.
It is common for a defined sample percentage of finished products from each batch to undergo an ‘incubation’ process to ascertain the lack of microorganisms within finished products. This supports the effectiveness of the time and temperature controls of each processed batch of product. Incubations are commonly conducted at 37 degrees Celsius or 99 degrees Fahrenheit, an ideal temperature for the growth of any potential micro-organisms contained within the processed product. Generally, if the products being incubated do not show any signs of bloating or vacuum, it is assumed that the Commercial Sterility process has been successful.
As the methods and techniques used for Commercial Sterility Processing are long-established, and have a strong validated and verified history of achieving their intended food safety goals under controlled conditions, products are commonly not required to be microbiologically tested on a scheduled basis. Though the Commercial Sterility process should always achieve consistent results when conducted in a controlled and verified manner, it is important to consider that analytical microbiological testing can provide substantial evidence of product conformance to Commercial Sterility standards. In this context, it is of utmost importance for the analytical microbiological testing of Commercially Sterile products, when conducted, to ensure that the product within its original packaging is not contaminated as an element of the sampling or testing process.
Packaging Materials used in the canning process are made from a thin steel strip coated with a thin layer of tin on the internal and external surfaces. In many cases, the interior of cans is lined with an organic compound to separate the food from the tin lining to prevent any chemical reaction. A rubber-like compound helps to form a hermetic seal when the bottom and lid are seamed onto the body of the can.
Once canned food is produced, poor transportation or storage practices might cause problems through denting or damage to the can seams. The leaks resulting from damage can allow contamination to enter the can which may allow spoilage to occur. Poor handling and storage conditions over time may also result in rusting of the outside of the can. Rusting commonly occurs when cans are stored in high humidity conditions, and is normally just unsightly, but can cause leakage over extended periods.
Badly dented cans should not be used and should be drawn to the attention of the management of the store from where they were purchased. If the can ends are bulging, return the can unopened to the supplier as the contents might be contaminated. This may potentially indicate a significant risk to consumers. Cans that have stained labels may indicate poor storage practices and a possible leak; These should also be rejected if identified.
The hermetically sealed contents of canned food are uncontaminated before opening, so great care should be taken to ensure contaminants are not introduced when the can is opened. It is considered best practice for the top of the can to be washed before opening. This will ensure that any dust or dirt in the can top will not enter the food during the opening process.
When opening canned food, a clean, sharp can opener should be used. Because the metals used in the construction of the can are relatively soft, the use of a blunt can opener can potentially introduce small pieces of metal into the food contained within the can. Blunt can openers also leave jagged edges which can provide health and safety risks. Can openers should ideally be washed after each use to further avoid the risk of contamination.
Once opened, canned foods should be treated as fresh foods. After opening, foods should be immediately removed from their can and placed into a non-reactive container with a tight-fitting lid, and stored within a refrigerator. Canned foods should be stored under refrigerated conditions and used within a suitable time frame, as they will spoil after the hermetic seal on the can has been breached.
Aseptic processing and packaging is a complex technique as it relies on a minimum of three different sterilization techniques to be effective.
As elements of aseptic processing and packaging methods, sterilization is conducted:
Failure of any one of these three techniques may result in an unsafe end product. In this context, the consideration of potential microbiological contamination points within an aseptic packaging facility must be addressed in a holistic sense.
For example, in a canning operation, if the product or package is contaminated before the retorting process, all bacteria and spores will be destroyed through the time and temperature process for the sealed can. A similar instance within aseptic packaging, where the product or packaging was not sanitary, would result in an unsafe product, as there are no further kill steps after the product has been packaged.
Flexible packaging for commercially sterile food products are becoming increasingly popular due to its versatility and reduced processing times, which can be reduced dramatically compared to packaging such as cans. Additional advantages for manufacturers include reduced shipping costs and storage space for empty flexible packaging, such as pouches. Whilst flexible commercially sterile packaging does have advantages in its application, challenges including seal integrity and more complex filling systems are required. Flexible commercially sterile packaging also requires significantly less heat than cans to achieve commercial sterility.
A typical commercially sterile pouch is a heat resistant bag made of laminated plastic films or foil, commonly consisting of an outer layer of polyester or nylon for printing, coding, and protection, a middle aluminum foil layer that functions as the principal oxygen and water vapor barrier and an inner or food contact layer of a heat sealant material such as polypropylene. Products are filled aseptically and sealed, or sealed and sterilized by pressure cooking in a retort to produce commercially sterile finished products.
Indirect heating involves the use of circulating the product undergoing UHT around partitions that are themselves heated or cooled according to the relevant process. Within this method, the heated or cooled medium on the non-product contact side of the partition transfers its heat or chill to the product undergoing the UHT process without physically contacting the product. The equipment used to heat the product within this method is also commonly referred to as a Heat Exchanger.
Heat exchangers are commonly available in three different types:
There are two main modern UHT processing methods used within food industries. Both methods utilize heating, but the variants available include the application of direct and indirect heat to the product being treated. The method used relies on the quality and volume of the item being subjected to the UHT process.
Direct heating usually involves subjecting the product to steam under controlled conditions until a nominated temperature is achieved for a nominated timeframe, after which the product is rapidly cooled within a vacuum vessel. The application of rapid heating and cooling gives a minimal sustained heat-load on the product, which results in a high-quality end product.
Water is commonly used as an element of the initial cooling process for commercially sterile products. Any water sources used for product cooling must be chlorinated or treated in a manner that will not introduce potential microbiological pathogens into foods during the cooling process.
This is particularly important for canned products, as the nature of the metal used in the construction of the can is prone to expansion and contraction during temperature and pressure variations. Potential contamination of foods within the can may occur at the can seams or ends. If water sources used to cool retorted items are chlorinated and sterile, they will not contaminate the product inside the can. Water used for cooling processes for commercially sterile commonly contains at least 5 parts per million of free chlorine.
Additional cooling is commonly facilitated after the items have been removed from the retort within a well-ventilated area.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Development requirements in relation to their items.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Commercial Sterility Processing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Documentation requirements in relation to their items.
You may wish to visit the Commercial Sterility Processing Templates section of haccp.com for examples of Commercial Sterility Processing documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Commercial Sterility Processing within any food business requires genuine commitment from senior management, staff, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcome of Commercial Sterility Processing does not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Commercial Sterility Processing must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Commercial Sterility Processing within a food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and or self-adjusted when variances are identified. Regardless of the system used; the goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Commercial Sterility Processing monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
The following examples of monitoring activities and record formats may apply to Commercial Sterility Processing:
Commercial Sterility Processing have been met. Other process parameters such as retort unit pressure and chlorine content and pH of cooling water are also commonly monitored.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Monitoring requirements in relation to their items.
You may wish to visit the Commercial Sterility Processing Templates section of haccp.com for examples of Commercial Sterility Processing documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation from the Quality System occurs, particularly in relation to a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure identified non-conformance issues are documented, investigated, and rectified within appropriate time frames.
Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability.
Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcome of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Commercial Sterility Processing related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans, and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to Commercial Sterility Processing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality system elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any inappropriate limits of control or acceptability are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the validation process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for Commercial Sterility Processing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specific job-related task.
Training and competency requirements for Commercial Sterility Processing must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Commercial Sterility Processing should have knowledge including:
Team members who have defined responsibilities regarding Commercial Sterility Processing should have skills including:
Team members who have defined responsibilities regarding Commercial Sterility Processing should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Commercial Sterility Processing Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.