Cleaning & Sanitization in health care manufacturing Industry

Mr. Pankaj this is the introductory part based on your mail at aav few days back. I will attach a series of attachments later as and when I prepare.

Cleaning and sanitization is essential to ensure microbial quality in the manufacture of Health care products. These procedures should be validated in order to consistently meet hygienic manufacturing requirements. The design of these procedures should take into account the product formulation and all aspects of manufacturing
Specific internal programs for cleaning and sanitization should be established. These programs are essential to :

Assure the microbiological quality of the product
Meet legal regulations where required
Minimize the microbial load contributed by processing, filling, and storage equipment
Avoid the cost associated with microbial failure
Help maintain the company commitment to quality

TRAINING :Personnel should be properly trained and supervised in the cleaning and sanitization of the facility and equipment. A document should be written to outline the training process. Ongoing training should be conducted according to a pre-planned schedule. Performance should be monitored to verify that the training is effective and proper procedures are being followed.

[b]Purpose : Training should be used to:
Bring new employees to the required level of competency.
Introduce new cleaning and sanitization methods and products to all employees.
Reinforce existing programs.
Conduct re-training according to a predetermined schedule, with more frequent training if needed.
Content :A training program should impart an understanding of the elements listed below and
how they affect product quality:
Overall microbiological awareness and basic microbiology
Basic concepts of microbial contamination, common contamination sources, and their avoidance
The consequences of microbial contamination and the risks associated with not following appropriate sanitary practices

Sanitary practices
Good housekeeping
Personal hygiene
Equipment operation and design
The importance of cleaning and sanitization and a clear understanding of each process
Product type and proper procedure based on product formula ingredients
Proper and safe use of cleaning and sanitizing agents
Concentration, dilution, and contact time of cleaners and sanitizers
Product and chemical residues, including cleaners and sanitizers
Training should also include:
A review of the procedure for proper cleaning and sanitization of the equipment and areas in their care
Effects of changes to process, formula or equipment changes on cleaning and sanitization requirements (i.e., change control)
Recordkeeping of cleaning and sanitization performed
A mechanism for reporting to appropriate personnel any observations that indicate a potential for contamination[/b]

Logs :The routine log should include the following information for each cleaning, sanitizing or changeover activity

Date, start and end times of the cleaning

Date, start and end times of the sanitization; include expiration time

Product and batch preceding the cleaning and sanitization

Operating procedure, SOP, or procedure number for the cleaning and sanitization being carried out

(Any variation from the established operating procedure should be recorded.)
Sign off by operator
Review, approval and sign off by verifier/reviewer

Time, date and identity of next batch start up

Date and description of any repairs or equipment down time

Status :In addition to permanent logs, current cleaning and sanitization status should be clearly displayed on equipment.

Examples of status designation labels are
Contents and Batch or Lot Number
Empty Needs Cleaning
Needs Cleaning
Clean Needs Sanitizing
Information on equipment status should also note the date sanitized and the expiration time and date.

Aqueous cleaners are typically formulated to contain several ingredients to allow for maximum cleaning effectiveness. The ingredient requirements depend on the intended use of the cleaner. Efficient aqueous cleaners utilize surfactants (anionic, nonionic,cationic and/or amphoteric), dispersants, emulsifiers, wetting agents, builders, chelating agents, sequestering agents, corrosion inhibiting agents and stabilizers. The surfactants are used for emulsification, wetting and penetration; builders for neutralizing hard water interferences, chelating inorganic soils and saponification of natural oils; and
additives for corrosion inhibition, anti-redisposition and good rinsebility.

Characteristics essential to a good cleaner include

Compatibility with equipment, i.e. non-corrosive
Quickly soluble
Good wetting action
Good penetration properties
Good emulsification and soil dispersion properties
Good rinsing properties
Economical and readily available
Environmentally friendly and non-hazardous

A sanitizer is either a chemical or physical agent that is effective in reducing microbial contamination on product contact surfaces. A sanitizer should achieve a 99.9% [3 log] reduction of pathogenic or unacceptable microorganisms and reduce other organisms to a minimal acceptable level. A sanitizer may be considered effective if it reduces microorganisms to acceptable levels, with no detectable objectionable microorganisms, as determined by the cleaning and sanitization protocol.

The following are desirable characteristics of a sanitizer
Effective against a broad range of microorganisms.Provides adequate microbial reduction, 99.9%, effective against organisms of concern.
Effective in a relatively short contact time.
Stable and efficacious over time, both in concentrate form and at use levels.
Economical to use.
Non-toxic at use levels.
Compatible with equipment.
Free from objectionable odors and residue.
Meets regulatory requirements.

The following process variables should be considered, specified, and controlled to ensure consistent sanitizer performance.

Condition of equipment surfaces

Materials of construction

Concentration of sanitizer

Contact time


Optimal pH range.

Mechanical energy (pressure and flow rate)[/b]