Contamination And Cross Contamination Precaution To Avoid Mix-Up

 OBJECTIVE:

To lay down the procedure for precautions to be exercised to avoid mix-up, contamination, and cross-contamination.

RESPONSIBILITY:

All originating Department employee responsibility to following the SOP.

All originating Department/Section Heads responsible for complies with this SOP.

IPQA/QA shall be responsible for Compile the SOP.

ACCOUNTABILITY:               

The Accountability of implementation and compliance of the SOP is of QA Head.

PROCEDURE:

Definition of Contamination: 

Any substance, which can spoil the product by physical or chemical means. Contamination is the presence of foreign substances in our products. It may be minor & unwanted constituents in a material, in the physical body at the workplace, etc

·         Physical: Hair, Foreign objects, dist, pollens.

·         Chemical: Cleaning agents, lubricants, other products.

·         Microbiological: Bacteria, molds, spores, yeasts.

Definition of Cross-Contamination: Cross-contamination of product is caused by either:

Contamination of a batch with a previous batch of the same product.

Contamination with a different product through carryover or proximity of the production line.

Contamination by a foreign starting material usually of the dispensary or in the stores.

The prevention of Cross-contamination requires:

The proper sealing, separation, and storage of raw materials, packing material.

Care in management of the dispensary so as to exclude the opening of different lots of containers in close proximity

Re-inspection of equipment before use and line clearance at all stages of manufacturing.

Ensuring all AHU systems are serviced and properly maintained.

When the same tools like spanners, screwdrivers, and other machine parts are used on a different machine with proper cleaning.

Wearing cleaned clothes correctly, as instructed, and entering into production area will prevent contamination. Using protective clothing inside areas where products with a special risk of cross-contamination are processed – Secondary change rooms are provided for manufacturing areas.

Avoiding wearing personal belongings like watches and other jewelry.

Following the airlock procedures, prevents contamination.

Adequate training of employees on dressing procedures would result in a decrease in microbial load and other severe problems.

Not wearing the hand gloves (surgical in primary packing area) while repairing the machines, will lead to contamination.

Following the cleaning schedules strictly in the production area. Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination – The cleaning procedure is well validated. In addition to this testing for residues is done by Swab Testing and Rinse water analysis as per SOP No. SOP-QA-010. Use Clean Status Labels on equipment after clearance.

Maintaining the required temperature and humidity in production area Usage of lubricants, not more than the required quantity for machines.

Complete vigilance and care at all the points shall ensure the absence of any form of mix-ups and cross contamination.

Receiving and storing the raw materials shall be done systematically and carefully as per respective SOPs.

Sampling shall be done as per respective SOP with all the precautions to avoid contamination.

Dispensing of materials shall be done as per respective SOPs to avoid contamination. Colors and flavors shall be dispensed at last.

During manufacturing operations line clearance shall be performed at all stages to avoid cross-contamination.

Avoid transfer of Raw Materials from the Original Container and re-labeling.

Proper labeling of dispensed raw materials and in-process containers during various manufacturing operations.

Avoid Use of the same containers for un-lubricated and lubricated granules for different batches.

Use of Dies and Punches with a proper Identification mark.

Keeping the raw materials of two products together in the same place with proper segregation.

Particular attention shall be paid to the personnel hygiene and uniforms of the Casuals as well as Staff.

Clean rooms and Cross-contamination: The prevention of cross-contamination is also accomplished by the use of positive air barriers (to exclude other products), dust extractors containment hoods (to trap and remove dust) during processing. Clean rooms are specifically designed so the airflow patterns and room pressures protect the product if is very important to maintain this protection by:

Keeping door closed (to prevent loss of pressure)

Keeping air returns clear (to maintain sweeping of air)

Cleaning extractors and filter (for efficient operation)

Checking room monitors (to verify set pressures)

Regularly maintaining/servicing air handling units (AHU)

Contamination of a starting material of a product by another material or product must be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapor, sprays, or organisms from materials and products in process, from residues on equipment, and from operators' clothing. The significance of this risk varies with the type of contaminant and of the product being contaminated. Products in which contamination is likely to be most significant are those administered by injection and those given in large doses and/or over a long time.

Contamination or Cross-contamination shall be avoided by appropriate technical or organizational measures, for example

 If you have any infections, colds, coughs, stomach up-sets, or if you have   any cuts or grazes, these must be reported to your supervisor, so that you   can temporarily be given work where you can do no harm.

Eating, drinking, chewing  and smoking are not permitted in   production and stores  areas, or not should food, drink, sweets,  smoking materials, and personal medicines are taken into these areas.

Always check that your work-place and surroundings are clean and tidy. Always check that equipment and containers have been properly cleaned before you use them.

During manufacturing operations line clearance shall be performed at all stages to avoid cross-contamination.

Quality Assurance personnel conduct a systematic Vendor Evaluation to eradicate chances of contamination or cross-contamination at their end. Following are the steps followed:

Vendor Audit to identify any potential source of cross-contamination of substance supplied.

Periodic re-inspection shall be done for the manufacturing unit supplying more than one item.