Specification, Certification and Accreditation

Question 1

stating what the plant is supposed to do and the resources required for this

Answer 1

specification

Question 2

evaluation of all parts of the installation measured against existing standards

Answer 2

certification

Question 3

declaration by a neutral third party that the certification program is administered in a way that meets the relevant standards or norms

Answer 3

accreditation

Question 4

Benefits of certification

Answer 4

• Traceability
• Safety of plant and surrounding area
• Established suitability for intended purpose
• Established suitability in hazardous environment
• Established suitability in hygienic processes

Question 5

Ensures that the correct certificatation and documentation has been obtained

Answer 5

Accreditation

Question 6

Global Standards

Answer 6

Ensure that branded products are of identical specification independent of country of manufacture
Staff are familiar with equipment when working in different countries
Proof that the company is operating safely and ethically

Question 7

Ensure the material used in construction is not affected by the process fluid, and the process fluid is not contaminated by the material

Answer 7

Material certificates

Question 8

Refer to the hygienic design of the device

EHEDG or 3A

Answer 8

Hygienic certificates

Question 9

What EHEDG stands for

Answer 9

European Hygienic Engineering & Design Group

Question 10

Ensure that the device complies with local legislation

Answer 10

Conformity certificates

Question 11

Ensure the device is factory tested and is accurate within set limits

Answer 11

Calibration certificates

Question 12

ensure the device can be used in explosive environments

Answer 12

Intrinsically Safe Certificates (ATEX)

Question 13

Refer to the level of protection that instrument housing provides

Answer 13

Ingress protection (IP) rates

Question 14

Probability of failure on demand

Answer 14

Safety integrity level

Question 15

Higher SIL means

Answer 15

• greater consequences
• lower acceptable failure rate
• higher levels of protection required from safety systems

Question 16

Probability of a system failing to respond to a demand for action from a potentially hazardous condition

Answer 16

Probability of failure (PFD)

Question 17

Different levels of protection

Answer 17

Independent protection layers (IPL)

Question 18

Order of priority of independent protection layers

Answer 18

1) Process design
2) Critical alarms
3) Automatic SIS (safety instrumental systems)
4) Relief devices
5) Plant response
6) Community response (run away)

Question 19

Used to determine the process hazards and risks and the level of protective layers

Answer 19

Process Hazard Analysis
Hazard and Operability Study

Question 20

Examples of processes that will also need certification

Answer 20

• processes to produce pharmaceuticals

Question 21

what the process and laboratory testing has to follow

Answer 21

Good Laboratory Practice

Question 22

Cleaning the interior of pipes and other fittings without disassembly

Answer 22

Clean in Place

Question 23

Clean in Place proceedures for pipes

Answer 23

high flow rate turbulent flow of clean solution

Question 24

Clean in Place proceedures for vessels

Answer 24

spray solution to wet the surface (high or low energy)

Question 25

How to improve CIP results

Answer 25

- Higher temperature - Higher pressures - Higher concentrations of solution

Question 26

Factors that affect the ability to clean

Answer 26

- Large pipe radii are better than sharp bends - Threaded connections are inherently unhygienic - Welds are better than removeable joints - Anything that penetrates into the flow path has potenital to accumulate residue such as obstructions and constrictions

Question 27

Often follows CIP

Answer 27

Sterilisation in place (SIP)

Question 28

Steam treatment to remove microbiological activity. Sterilises the equipment with hot steam. Needs a certain temperature and duration for sterility

Answer 28

Sterilisation in place ## Footnote Pressure hold test before SIP to check to leaks Temperature probes needed to verify high enough temperature as expected cold spots. These might be additional to those needed for normal processes. Need to drain concentrate. Then flush with sterile gas

Question 29

using rubber 'pigs' to help to clean pipes

Answer 29

pigging

Question 30

When pigging is not suitable

Answer 30

- large radius - elbows are not suitable - sharp bends

Question 31

Benefits of pigging

Answer 31

- less waste product -> increasing yields - Less water use - Faster CIP, change overs - Reduced carbon foor print - More efficient operation increasing profits - Pig can be used to prevent aeration of product which is ideal for wines, frothing liquids, etc.

Question 32

Allows for easy installation and removed when necessary Lowest pressure rating of three options Prone to leakage Not recommended for applications with toxic, explosive or corrosive materials or hygienic applications

Answer 32

Threading

Question 33

Permanently welded to process pipes tanks Removal requires cutting device out of the system. Highest pressure rating and generally used in applications with high velocity flow, high temperature or extreme pressure. They are necessary where a leak proof seal is required

Answer 33

Welding

Question 34

Bolted to a mating flange that is welded onto process pipe or tank. They provide high pressure ratings, easy installation and simple replacement. Used in applications with corrosive environments, high velocity, high temperature or high pressure

Answer 34

Flanged joints