Sterile Products And Aseptic Techniques.pdf

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Sterile Products and Aseptic Techniques

CHAPTER

for the Pharmacy Technician

Quality Control and Assurance

9

The Seven Rights

Quality Assurance Functions

• Written policies & procedures

• Documentation

• Personnel training

• System checks & process validation

• Daily assessment of all operations

Quality Improvement (cont’d)

• Process includes

– Monitoring trends

– Conducting audits

– Identifying & analyzing problems

– Taking corrective measures

– Conducting testing

– Suggesting change

FDA

• Publishes Good Manufacturing Practices

(GMP)

• GMP covers compounding sterile products

• Other guidelines: manufacture of sterile

products

• Guidelines include quality system

regulations

Guidelines (cont’d)

FDA (cont’d)

• Regulations make standards consistent

with requirements

Guidelines (cont’d)

ASHP

• Publishes Guidelines on Quality

Assurance for Pharmacy-Prepared Sterile

Products

• This document

– Outlines considerations that are subjected to

quality testing & assurance

– Addresses all areas impacted by quality

assurance

Guidelines (cont’d)

USP

• Published USP Chapter 797

– First enforceable national standards for sterile compounding

– Adopted by state boards, JCAHO, FDA

Miscellaneous

• Other local, state, & national agencies

• Find out what rules apply in your state

ASHP Guidelines on QA for

CSPs: Risk Level 1

• Products that are

– Stored at room temperature

– Completely administered within 28 hrs of prep

– Unpreserved

– Sterile

– Prepared for administration to >1 patient

– Prepared by closed-system aseptic transfer

ASHP Guidelines on QA for

CSPs: Risk Level 2

• Products that are

– Administered beyond 28 hrs after prep

– Stored at room temperature

– Batch-prepared without preservatives

– Intended for use by >1 patient

– Compounded by complex, numerous

manipulations using closed-system aseptic

transfer

ASHP Guidelines on QA for

CSPs: Risk Level 3

• Products that are

– Compounded from nonsterile

USP 797: Low-Risk Level CSPs

• Any CSP that is prepared

– Using proper aseptic technique

– In an ISO Class 5 or better environment

– Using only sterile ingredients & supplies

– With 3 or less commercially available

products/packages– With 2 or less entries into any one sterile IV

bag or vial

USP 797: Low-Risk Level CSPs

(cont’d)

• Any CSP that is prepared (cont’d)

– Limited to

▪ Opening ampules

▪ Transferring liquids in syringes to sterile containers

▪ Penetrating disinfected vial stoppers

– At least 48 hrs storage @ room temp

– 14 days or less refrigerated

– 45 days or less frozen

USP 797: Medium-Risk Level

CSPs

• Any CSP that is prepared (cont’d)

– As more than 1 individual or small doses

USP 797: Medium-Risk Level

CSPs (cont’d)

• Any CSP that is prepared (cont’d)

– 30 hrs or less storage @ room temp

– 9 days or less refrigerated

– 45 days or less frozen

USP 797: High-Risk Level CSPs

• Any CSP that is prepared (cont’d)

– By compounding using nonsterile ingredients

– Using sterile contents of commercially

manufactured products– Without antimicrobial preservatives

– Exposed to less than ISO Class 5

environment for more than1 hr– By improperly gowned personnel

USP 797: High-Risk Level CSPs

(cont'd)

• Any CSP that is prepared (cont’d)

– With nonsterile water-containing products that

are stored for more than 6 hrs– 24 hrs storage or less @ room temperature

– 3 days or less refrigerated

– 45 days or less frozen

– After any servicing of facilities & equipment

– As part of periodic recertification of

facilities/equipment

– In response to

▪ Issues with compounded sterile products

▪ Observed improper technique of personnel

USP 797: Environmental

Sampling Testing (cont’d)

• Should occur (cont’d)

– In response to

▪ Issues with compounded sterile products

▪ Observed improper technique of personnel

▪ If a CSP is a potential source of patient-related infection

USP 797: Cleaning & Disinfecting

USP 797: Cleaning & Disinfecting

of Compounding Area (cont’d)

• Counters, work surfaces, floors must be

USP 797: Other Guidelines

• Policies & procedures

– Needed in every pharmacy

– Address updating, accessibility to personnel,

accuracy, SOP, monitoring

– All personnel must know policies &

procedures

USP 797: Other Guidelines

(cont’d)

• Personnel, education, & evaluation

– Personnel must constantly

USP 797: Other Guidelines

(cont’d)

• Storage & handling inside & outside

pharmacy

– How drugs are packaged, prepared, delivered

– Need for refrigeration

– Risk of contamination if stored/handled

improperly

USP 797: Other Guidelines

(cont’d)

• Facilities & equipment

– All compounding areas are held to high

USP 797: Other Guidelines

(cont’d)

• Aseptic technique, product preparation, &

garb

– Manufacturing processes

▪ Require constant evaluation & improvement

▪ Have many checkpoints

– Focus on prevention of microbial

contamination

USP 797: Other Guidelines

(cont’d)

• Process validation

– Documenting/proving that process will

consistently produce product meeting

specifications

• End-product evaluation

– Pharmacist’s “final check”

– Inspections with periodic sampling/testing of

batches manufactured under same conditions

Documentation and Labeling

• All products dispensed must be labeled

• Every piece of equipment must have

records

• SOPs illustrate how a product is

made/processed

• Required patient info for each product

– Patient diagnosis, IV regimen, dosages, BSA, lab values

Documentation and Labeling