Mix up
Mix up can be defined as taking something which is not subject to take; taking one thing to another. Taking wrong item unintentionally which can be easily identified such as taking Aceclofenac tablet in place of Metronidazole tablet having different size and shape. Mix up is a mix of diverse item but essentially contaminated. For example one blister strip of batch [A] tablet found with another batch [B] tablet.
Mix up is
- Assume wrong item to right thing
- Failure to take right action on due time
- Mixture of various item/elements
- Selection of wrong item
- Selection similar product/material/item
- Unintentionally taking one thing to another
- Wrong selection of desired material
- Wrong action taken due to lack of attention
Probable cause of Mix up
- Breakdown of processing equipment.
- Collation/procure similar packaging/printed material from same vendor.
- Conducting packaging operation in other than main packaging belt.
- Discontinuous packaging/partial packaging of single batch.
- Engaging untrained/partial trained personnel.
- Engaging single operator to multiple packaging line.
- Failure to follow written procedure for line clearance.
- Inappropriate labelling.
- Improper segregation of products/item during manufacturing operation.
- Improper labelling during dispensing.
- Inadequate controls.
- Manual operation other than automated system
- Multiple product packaging operation in insufficient packaging area.
- No barcode/QR code/Identification code
- Process validation not properly conducted
- Previous batch item such as label, carton, accessories etc. not removed properly
- Rejection material handling
- Reprocess
- Rework
- Return of IPC checks item to the wrong/ similar packaging belt.
- Repackaging and packaging of similar product/item.
- Similar Size, shape, color of multiple products.
- Similar design of primary packaging/secondary material.
- Similar product line clearance in same time.
- Same instruments/apparatus use for multiple item/products/material.
- System failure
- Wrong labelling
Contamination
Contamination can be defined as the presence of undesirable element, impurity or constituent which infects, corrupts, spoils, makes substandard or makes unhealthy a factory, normal environment, physical body, material, process steps, bulk, liquid, granules, solid etc.
As per US FDA, contamination can be defined as-
Type of Contamination
Non-Viable
Liquid or solid particulate contamination range from 001 and 1000 microns such as smoke, dust, fogs, fumes, and mists.
Viable
Particulate contamination that supports, or consists of one or more live microorganisms such as Viruses, Bacteria, and spores.
Sources of Contamination
- Atmosphere
- Clothing
- Equipment
- Fluid
- HVAC System
- Manufacturing Debris
- Premises
- People
- Processing Operations
- Surface
- Utilities and Services
Various source of contamination has been illustrated on the respective table-
Contamination of products can be caused by:
- Contaminated dress/attire
- Contaminated equipment/apparatus/instruments
- Contaminated or damaged HVAC system
- Contaminated Premises/sites/areas
- Individuals, e.g., carrying harmful bacteria
- Processing Operations negligibly
- Utilities/Services/facilities
Cross Contamination
Cross Contamination can be defined as unintentional transfer of chemical contaminants, microorganism from one person, food, and object to another person, food.
Risk of cross contamination
The involving risk of cross contamination depends on the type/class of contaminant and which product or item will be affected.
The most hazardous contaminant are;
- Allergens
- Biological item/product/living organisms
- Hormones
- Sensitizing materials
- Toxic materials/Item
Sensitive product for contamination
- Administer booster doses
- Injections
- Prolong period of time
- Product Applied to open wounds
- Cytotoxic agents
Consequences to Company
- Company image crisis
- Financial losses
- Loss of Company reputation / Adverse Publicity
- License cancellation
- Market share down
- Product Recall
- Show cause notice
- Shutdown of premises
- Vigorous audit by regulatory authorities
- Withdrawal of product
- Warning letter
Employee Consequences
- Financial losses
- Jail / Penalty
- Reputation loss
- Personal Image crisis
- Suspension order
- Show cause notice
- Termination of services
Minimizing the risk of cross contamination
Minimizing the risk of cross contamination from mix up
- Allocation and utility connect expertise that are exclusive to the process
- Bar coding, QR coding, and RFID of materials and equipment’s
- Distinct dispensing areas
- Enormous Electronic confirmation of material
- Enormous manual check
- Isolated raw material staging area with proper labelling
- Using of Color coding
- Using of Locked and key Stainless steel cages to store APIs with chain of safekeeping
- Using of PAT [Process analytical technology, i.e. NIR]
Minimizing the risk of cross contamination from residue carryover
- Cleaning validation
- Distinct product contact parts
- Equipment design for CIP and SIP
- Single use product contact parts
- Process Analytical Technology [PAT]/online monitoring
- Setting of cleaning limit
- Set base limits on statistical analysis, science, and risk assessment
Minimizing the risk of cross contamination from Mechanical Transfer
- Airlocks system
- Cleaning mobile equipment’s/machine in processing room/area
- Encompass at the source
- Gowning procedures
- HSG [High Shear Granulator], Milling and Drying in same suite
- Limiting the transfer of compounds between same suits
- Room Airflow
- Separate work areas to a single product
- Sprinkling showers
- Wipe down protocols for mobile equipment’s
Minimizing the risk of cross contamination from Air borne transfer
- Airlock separation to corridor
- Appropriate Room air changes rate
- Comprehend the source
- Close process systems
- Gowning procedures
- Room differential pressure
- Sufficient Room airflow
- Sparking showers
Also read
Cross-contamination prevention during processing in pharma industry