Definition of spores

Spore-forming bacteria. When certain bacteria grow, they have the ability to develop
resistance to extreme heat, dryness and chemicals. These bacteria are called spore formers
because they develop a "shell" which is capable of protecting the cell under adverse
conditions

Concept of sanitation
It is important to differentiate and define first certain terminology:
Sterilize refers to the statistical destruction and removal of all living organisms.
Disinfect refers to inanimate objects and the destruction of all vegetative cells (not
spores).
Sanitize refers to the reduction of microorganisms to levels considered safe from a
public health viewpoint.

Types of sanitation
Thermal Sanitization involves the use of hot water or steam for a specified
temperature and contact time.
Chemical Sanitization involves the use of an approved chemical sanitizer at a specified
concentration and contact time

Study of the CLEANING IN PLACE

Cleaning in Place (CIP) is a method of cleaning designed to clean interior surfaces of
tanks and pipelines of liquid process equipment. In essence consists on making a
chemical solution to circulate through the circuit of tanks and lines and then return it to a
central reservoir allowing for reuse of the chemical solution. Time, temperature, and
mechanical force are manipulated to achieve maximum cleaning. A (CIP) can be
composed of the following steps:
Pre-rinsing.
Caustic treatment.
Intermediate rinsing.
Acid treatment.
Intermediate rinsing.
Disinfection.
Final Rinsing.

Control of efficiency of CIP systems

The control of (CIP) is a two part operation. The first involves managing the process
itself to ensure that every part of the cleaning cycle is performed optimally. This does
not normally involve any microbiological procedures; it consists of monitoring such
things as time, temperature, detergent concentration, flow rates etc. The second
part involves assessing whether the procedures have been effective and this is where
microbiological controls are often used. Traditionally microbiological methods have not
had a role to play in ensuring CIP effectiveness but have been used solely for
assessment. With the advent of new rapid systems this is beginning to change. The main
reason for the lack of application of microbiological methods for quality assurance is one
of speed. In order to be able to control a process it is necessary to obtain information in

real time. Techniques which measure physical or chemical characteristics can provide a
response rapid enough to enable operational decisions to be made.

Methods for Ensuring Cleanliness of Plant: operational parameters

These methods are not microbiological in nature they are essential for effective control of
CIP operations. If these checks are not in place the failure of the cleaning procedure is a
certainty and any subsequent microbiological investigations will be a waste of time and
effort. Many procedures are available for ensuring the effectiveness of (CIP).
Those include:
cycle times
solution temperatures
flow rates
Pressures
Additionally, a wide range of chemical analyses can be used including:
detergent concentration (using conductivity)
alkalinity (either in-line or off-line)
specific chemical activities (e.g. sequestrate concentration)
pH
soil load of detergent solution (this can be determined by measuring colour, suspended
solids,
Tendency to foam etc.)
causticity
A major advantage of this type of control is that it is immediate and the operator or the
automatic control system can react to the results in time to correct any problems.
However, despite the sophisticated control and measurement systems now available for
quality assurance of CIP procedures, there is still a need for ensuring that the process
has actually worked. This is an area where microbiological methods can take their
place alongside physical and chemical measurements.

Definition of UHT process

Post Process Contamination Concerns

Some references cited that typical spoilage in UHT production at a defect rate of 1/1000.
The following seven potential failure modes exist for aseptic processing and packaging of
dairy products.
- Type 1 failure results from raw ingredient, handling, storage, or batching issues.
- Type 2 failure results from processor and filler CIP, sanitation, preventive maintenance,
and pre-sterilization issues.
- Type 3 failure results from the thermal process heating cycle including regeneration.
- Type 4 failure results from the cooling cycle including surge tanks.
- Type 5 failure results from sterilization issues with the package.
- Type 6 failure results from sterility loss in the aseptic zone or from environmental load.
- Type 7 failure results from loss of package integrity. (Post process contamination occurs
in individual cartons if package integrity)
Contamination issues must be identified with subsequent corrective action. Post process
contamination of the aseptic zone can be attributed to several variables: environmental
bioburden, positive air pressure, processing equipment or line turbulence, system gasping,
indexing operations, condensate accumulation, unsterile product entry, or bacteriological

seeding, Contamination from isolated package integrity issues occurs more frequently than
processing contamination
Hydrolytic enzymes (proteases, lipases) from Pseudomonas species can survive UHT
treatment and result in rancidity and proteolysis). Bacterial cells communicate when adequate
levels of AHL (acyl homoserine lactones) are produced at threshold concentrations. This
quorum sensing is related to the production of protease and biofilm Examples of thermophilic
sporeformers most commonly found in UHT dairy foods include Bacillus stearothermophilus
and Bacillus licheniformis. These organisms produce acid without gas resulting in a flat
sour defect in the low-acid, thermal processed shelf stable foods. The thermophiles do not
grow under ambient storage/shipping temperatures as they have optimum growth at
approximately 55C. The fungus Fusarium oxysporum produces gas and is evident by
swollen or bloated containers. This organism enters the filling system through contaminated
air or when positive air pressure is lost in the aseptic zone
Contamination by Bacillus cereus indicates improper cleaning and sterilization of the UHT
system. Contamination through gaskets or condensate in the lower temperature sections of
the processor are indicated by a single organism, whereas package integrity or packaging
sterilization issues typically result in a flora of microorganisms

Quality Assurance & Quality Control Aspects

Quality assurance is a program to ensure the product meets company specifications, audits,
trainings and local standards, whereas a quality control program focuses on the production of
non-defective product. , monitoring raw materials, batches, in-process control points,
sampling, labelling, commercial sterility testing, regulatory inspections.

Dried milk
Drying is used, after evaporation, to produce a stable, powdered product with a
residual moisture content of 2 - 5%.
Dried milks spoilages
Relatively low numbers of microorganisms survive processing. Heat resistant
organisms (spore-formers and non-spore-formers) and mould are responsible for
deterioration of milk powders, if the product is allowed to absorb moisture during
prolonged storage. The aw of dried milks is otherwise much too low to support
microbial growth, and a general decrease in microbial counts occurs during
storage
Dried milk
Although dried milk products have been implicated in a number of foodborne
disease outbreaks, these have usually been the result of post-pasteurisation
contamination by pathogens. Foodborne pathogenic bacteria are unable to grow in
dried milk powders, but may survive for long periods.
Salmonella spp.
Staphylococcus aureus
Listeria monocytogenes
Bacillus spp.
Cronobacter and Enterobacter spp

Microbiology
The key to production of long-life products with aseptic technology is a detailed understanding of
the microbiology of food. Using the example of the dairy industry

Alkaline detergents (caustic) remove protein deposits and saponify fat whereas acid
detergents remove mineral deposits
The flow velocity and circulation temperature are critical in the CIP process
Cleaning should be completed at established frequencies to prevent residue and biofilm buildup. Biofilms may contain bacteria and spores within the matrix, adhere to equipment
surfaces, and resist removal during cleaning and sanitizing. The biofilms can detach and
contaminate the product being manufactured
Monitoring programs such as
ATP swabbing should be implemented to verify cleaning effectiveness

A major cause of failure of processing and packaging systems is the development

of biofilms on equipment surfaces. These communities of microorganisms develop
when nutrients and water remain on surfaces between times of cleaning and reuse.
Bacteria in biofilms (sessile form) are more resistant to chemical sanitizers than
are the same bacteria in suspension (planktonic form) (Mosteller & Bishop, 1993).
Chemical sanitizers may be rendered ineffective by biofilms leaving viable bacteria
to be dislodged into the milk product

A build up of biofilm and residual wash water indicates cleaning protocols are not being followe

Biofilm

A complex structure adhering to surfaces that are regularly in contact withwa

ter, consisting of colonies of bacteria and usually other microorganismssuch a
s yeasts, fungi, and protozoa
These adherent cells are frequently embedded within a self-produced matrix of extracellular
polymeric substance (EPS)