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Manufacturing Hygiene UKC Oct 13

7 steps QA Approach

Pers and Mfg Hygiene

Address

Consumer

Safety in the

Quality Policy

&

Disseminate

STEP-1

G.ppt

STATUTORY REQUIREMENTS / GMP - TEA COMPLIANCE

BEVERAGES

PRODUCT : TEA

PFA IN-HOUSE SAFETY TESTING

SL PFA PARAMETERS LIMITS LIMITS MARGIN @ FREQUENCY

NO (ON DRY BASIS)

A ANALYTICAL PARAMETERS ( A 14 )

1 TOTAL ASH ( % BY WEIGHT ON DRY 4 - 8 4.25 - 7.75 0.25

MATTER)

2 ASH SOLUBLE IN BOILING WATER 40 43 3

AS % OF TOTAL ASH (Min)

3 ASH INSOLUBLE IN HCL % BY WEIGHT 1 0.98 0.02 Blend paper wise

ON DRY MATTER Max

4 ALKALINITY OF SOLUBLE ASH 1.0 - 2.2 1.1 - 2.0 0.1 - 0.2

AS K2O BY MASS (%)

5 WATER EXTRACT OBTAINED BY 32 32.5 0.5

BOILING TEA IN WATER FOR 1 HOUR

UNDER REFLUX ( % Min )

6 CRUDE FIBRE % BY WEIGHT ON 17 16 1

DRY MATTER ( Max)

7 IRON FILINGS (PPM) - Max 250 -

8 MOISTURE (%) - Max 7.0 -

Ensure full

compliance with

Statutory /

Mandatory

Requirements

STEP-2

BRAND QUALITY OBJECTIVES

Understand the

changing

Expectations of

the Consumers ,

apply QFD &

Develop Brand

Quality Objectives

STEP-3

• Bacterial growth & survival are dependent on:

– pH

– Temperature

– Water activity (aw)

– Nutrition

– Presence/absence of antimicrobials or preservatives

Product & Process Design

RIGHT PRODUCT & PROCESS DESIGN

Design Robust

Product /

Processes

STEP-4

Good Manufacturing Practice - GMP

Design Control Points - DCP

HACCP

Ensure GMP / GHP before embarking on HACCP

STEP-5 Implement HACCP

Right Hardware / Infrastructure and

Implementation of GHP / GMP( Category)

• Pest Proofing

– Food Handling Area

• Building / Roof / Wall / Floor

drain

• Storage and handling

facilities

• Laboratory

• Personnel Hygiene

Infrastructure

– Hygiene Station at entrance

– Change room

– Toilet

– PPE

• Handling of lubricants /

cleaning aids / chemicals etc.

• Process robustness

(pasteurisation, handling

of preservatives etc.)

• Water management

• Air

• Valves

• Pumps

• Pipeline / fittings

• Heat Exchangers/Vessels

• Generic CCPs

• Cleaning & Disinfection

• Rework Handling

• Offline Processing

Plant & Building Infrastructure Manufacturing Hygiene & Design

STEP-6

PEOPLE

SYSTEM HARDWARE PRODUCT

Four Legs Of a Sound QUALITY SYSTEM

Delighted

CUSTOMER

&

Empowered

EMPLOYEE

STEP-7 Sound Quality & Con

Safety Mgt.Systems

Manufacturing Hygiene :

Preliminary Risk Assessment

• Identify critical points in design

• Identify missing data

• Identify key issues that needs

verification during factory visit

2. Inspection & Factory Visit

• Factory design & lay-out

• Personnel

• Product

• Process

FOCUSS ON HYGIENE

Factory Design & Lay-out

• Site & infrastructure

• Building design & lay-out

• Utilities

• Pest control




• Building design & lay-out • Utilities

• Pest control

Checklist

• Site location

• Access control

• Hard surface

• Potential sources of contamination

(e.g.waste water treatment, farms)





• Utilities

• Pest control Checklist

• Segregation, zoning, logical flow of people and product

• No direct opening of toilets, labs and social areas to production area

• Floors drainable, no cracks or broken tiles,

• Cleanability and cleaniness of floors, walls, drains, ceilings

• Condition and state of repair

• Windows (shatter proof) and doors closed or screened





• Utilities

• Pest control

Checklist

• Heating, ventilation & air conditioning (HVAC) condition, over-

pressures, air flow

• Adequate and protected lighting

• Water source, quality, and treatment

• Steam (culinary)

• Air (oil & water free), filter type

• Approved lubricants


Water Sources Principal Supply

Towns/Municipal

Other Supply

Well / Bore Hole

Surface Water

Typical Process Water Treatment System

WATER SOFTENER

BREAK TANK

BACK FLOW PREVENTER

DE

PT

H F

ILT

ER

AC

TIV

AT

ED

CA

RB

ON

FIL

TE

R

CA

TIO

N E

XC

HA

NG

ER

CA

TIO

N P

OL

ISH

ER

AN

ION

EX

CH

AN

GE

R

MAINS

FEED

MAINS

FEED

MAINS WATER SOFTENED WATER DEMIN WATER

CHLORINATION AND STORAGE

Water Treatment Components Depth Filter

– For removal of suspended solids in water

Activated Carbon Filter – For removal of organic contaminants in water

– Recommended disinfection weekly once, e.g. 90oC water for 1 hour

Water Softening – For removal of ions which give rise to scale ( e.g. Mg, Ca replaced by Na )

– Recommended monthly disinfection, e.g. by 500ppm available chlorine for

up to 30 mins

Demineralisation – For removal of both anions and cations

– Resin bed regeneration (acid+alkali) kills majority of micro-organisms

– Recommended annual disinfection

– Size units to ensure frequent regeneration

Process Water Distribution System

Should Be : Capable of disinfection

Complies with hygienic design principles

EITHER :

Supply Ring Main Continuous circulation

No “dead-ends”

No stagnation

OR :

Drainable :-

Empty + dry

No storage of unchlorinated water

Process Water System Design

No

“Dead-Legs”

!!!!

Water Decontamination METHOD Positive Negative

Heat ( 60 to 80degC )

No chemicals, canbe part of the

process

Capital cost, high energy ( todestroy viruses/spores ), noresidual effect, cool water

again ?

Ultra-Violet( UV Lamp )

Effective against allmicro-organisms, no

chemicals

Need clear / uncoloured /water, clumps/biofilms not

treated, lamp maintenance,no residual effect

Micro Filtration Effective against allmicro-organisms

Grow-through can occurRequires monitoring and

maintenance

Ozonation Effective against allmicro-organisms

Capital and maintenancecosts can be high, no residual

effect

SodiumHypochlorite

Reliable, ResidualProtection, Cost

Effective

Chemical residue, Noteffective against spores at

2ppm, By-products

Chlorine Dioxide Effective against allmicro-organisms

As for Sodium HypochloriteHarmful gas




• Utilities

• Pest control

Checklist

• Pest access prevented

• Control system in place by professional 3rd party

• Position of executors

Personnel Hygiene

• Hand washing facilities

• Changing facilities

• Sanitary facilities

• Clothing

• Skills & capabilities


Product

• Raw material storage and handling

• Product handling

• Product/intermediates storage and holding

• Rework

• Packaging materials storage and handling

• Storage finished product


Packaging Materials Good Practices

•Toxicological safety clearance

•Keep stock levels to just-in-time wherever possible

•Ensure FIFO operates effectively with clear labelling

•Store in clean, dry, and dust free conditions on pallets

•Cover primary packaging

•Maintain good housekeeping, particularly on residual

materials returned from production

•Dispose of old stock

For Packaging Materials

Processing

Heat:

Hot process above 70oC can decontaminate if

process time is sufficient.

Some preservatives are deactivated by heat, pH

or other ingredients.

Order of Addition of Ingredients:

Effect of Process Conditions on Microbiological Quality

Processing Bad Practices

Vessel manway / lids left open

Flexible hoses poorly managed (on floor, in pools of liquid)

Standards of temporary modifications

Lack of disinfection after engineering work

Inadequate manual cleaning of equipment ( e.g. hoses )

Main plant trials not including assessment of how to control hygiene risks

Lack of awareness of risks and consequences

Some typical examples of bad practices are / have been :

Packing

• Simple hand filling operations

• Semi auto or fully automatic machines

• Weigh fillers

• Volumetric fillers

• “Flow meter” fillers

There are a wide range of packing machines in use:

Each type has a different set of risks

None provide positive benefits in the form of lethal steps

Packing Process Risks

• Supply headers for machines

• Pipework, valves, and flexible hoses

• Dosing valves

• Filler nozzles

• Spillage

• Condensation

• Dust generation

Typical risk areas in packing machines are :

The risks must be identified

AND

procedures put in place to manage these risks

Bulk, High Risk, Liquid Raw Materials

Transport Tankers must be cleaned & disinfected prior to use and certified as such

Receipt Reception points must be clearly labelled, clean, dry and terminal

connections covered by end caps

Hoses and pumps part of cleaning and disinfection programme

Storage Storage must be in stainless steel stock tanks of hygienic design

Aware of condensation risk is material ‘hot filled’, then cools on store

Inspection access is essential

CCP

CCP

Drum/IBC, High Risk, Liquid

Raw Materials Intermediate Bulk Containers / Drums

If reused by supplier, should be cleaned, disinfected and dried prior to

refill

Tops should be clean to avoid contamination of contents on opening

- environmental dust

- rainwater

Drum stores must be covered

Connections / pumps used to off-load to be part of C&D programme

CCP

CCP

Process Specifications / Recipes

Specify

Batch sheets (or control system) must:

Record

Orders of addition

Final pH specification

Batch temperature

Processing times

Deviations and reasons

Double checks for key raw

materials (e.g. preservative)

Includes all stages and unit operations :

- manual operations

- premixes

- main mix

Could be several CCPslinked to the process routes

e.g. correct dosing of preservative

Premixes / Intermediates

Pre-mixes and Intermediates must also be handled in a hygienically secure

way

If the pre-mix or intermediate is potentially vulnerable to contamination a

decision needs to be taken as to whether it will be made up fresh or stored

If a risk premix or intermediate is to be stored then physical protection (

temperature or pH mostly ) or chemical preservation will be required

Cleaning and disinfection procedures need to be carefully considered.

• Process

• Line lay-out

• P&ID verification

• Equipment & components design

• Process control & records

• Operational procedures (e.g.start-up, shut down)

• Packaging

• Maintenance & calibration

• CIP routing (hardware)

• Cleaning & Disinfection procedures

• HACCP

Checklist

• Dead-ends, T-pieces

• Verify type of equipment and check detailed design (technical drawing

evaluation of complex equipment) in case equipment is not approved

• State of repair and cleaniness of equipment, leaking couplings, valves, pumps,

damaged seals

• Calibration

• CIP system construction, double seat valves, chemical dosing correct, safe

separation of CIP-product

• Pasteurisation/sterilisation conditions adequate

• PHE/THE intact, flow diversion, cooling

• Pipe construction, welding, corrosion,

• Materials of construction

• Tank design, sprayballs construction.


Hygiene assessment

Checklist, Pasteurisation/Sterilisation unit\

• Type of product pump

• Kind of heat exchanger

• Regeneration

• Type and position of temperature probes

• Type of flow diversion valve

• Type of pressure sensors

• Flash vessel, how constructed

• Back pressure valves (types and place)

• Coupling types downstream heating unit

• Type of sampling valves

Hygiene assessment

Checklist, CIP

• P&ID; clear routes of CIP connections

• CIP documented, validated

• Valve seat flushing

• Valve seat lifting

• By-passes cleaned

• Dead-ends in product lines

• Clear cleaning loops and no dead ends

• Cleaning of drain valves

• Draining after cleaning

Checklist Plant & Equipmt

• Type and model of filling machine

• Cleaning procedures

• Pre-sterilisation procedures

• Type of sterilisation

• Air filters

• Spray nozzles

• Water quality, sterile water loop construction

• Mechanical seals construction

• Stop-start procedures

• Cleanliness of filler during production

• Construction of filling valves

• Commissioning & validation of filling machine

Hygiene assessment

Process line components

• Heating unit (PHE, THE, steam injector, steam infusion)

• Components; valves, couplings, pumps, sensors, etc.

• Cooling system (PHE, flash vessel)

• Aseptic tank, post-dosing

• Aseptic filler

• SIP/CIP system design & procedures

Valve Types and Cleaning

Type CIP Comments

Lip Seal (mix-proof) Yes Suitable for fully automated systems

Butterfly Yes Many types, plenty which are

cleanable

Rising Stem (tank base) Yes Care with very viscous materials or

trapped solids

Diaphragm Yes Must orientate to allow draining

Plug No Operational difficulties; can CIP if

substitute spool piece for valve

Ball No Material trapped in annulus between

ball and body - new types claim to be

hygienic ?

Pressure Relief Some Material trapped beyond seal in most

types

Non-Return Some Care on design to minimise hold up

and heat sanitising is recommended

Gate No Don’t use them !

Pump Types and Cleaning

Type CIP Breakdown Weak Hygienic Features

Cleaning

Lobe Yes Yes Some models have

crevices / poor rotor

attachment

Centrifugal Yes Yes Seals and impeller

shadowing

Double Diaphragm Yes Yes Peripheral seal is the weak

point

Diaphragm / Piston Yes No Non-return valves and seals

Peristaltic Yes No Care for cracked hoses

Rotary Vane Yes No Sliding vanes poor

Barrel / Drum No Yes Complex interior requires

flushing

Progressive Cavity No Yes Seals and poor draining

Sine No No Complex interior design

with sliding parts

Gear No No Seals and crevices

in intermeshing

gears

Heat Exchanger Types and Cleaning Heat Exchanger Comments Overall

Rating

Plate and Frame Hygienic designs available, must be single

pass and self draining. Tell tale for leaks is

desirable. CIPable given correct flowrates.

Scraped Surface Hygienic designs exist, need to look at

individual cases. CIPable, must run

scraper during cleaning.

Shell & Tube Hygienic designs exist, need to look at

individual cases. CIPable in principle, but

even flow not guaranteed in all tubes.

Spiral

(Longitudinal/Annular)

Fundamentally unhygienic due to seal

configuration. Not cleanable.

Preferred

Acceptable

Caution

when

selecting

Not

Acceptable

Heat Exchangers Types

T H A N K Y O U

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