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SPMED03 Clean Room & Sterility

Overview Textbook Workbook Instructor notes Knowledge check

Knowledge check

Clean Room & Sterility Discipline

10 questions in pool · live exam draws 4

SPMED03

10 questions · live exam draws 4

Q1 multiple-choice · iso-14644

ISO 14644 is the international standard for:

A) Medical device classification
B) Cleanroom and associated controlled environments — defines cleanliness levels (ISO 1 strictest to ISO 9 unclassified)
C) Color accuracy
D) Risk management

Source: SPMED03 §1.

Q2 multiple-choice · typical-room

Typical PhotoRobot studio (outside clean room) is approximately:

A) ISO 5
B) ISO 7
C) ISO 9 (uncontrolled regular indoor room)
D) ISO 1

Source: SPMED03 §1.

Explanation: Standard rooms are ISO 9. Customer’s clean room may be ISO 7-8; PhotoRobot studio outside is ISO 9.

Q3 scenario · sealed-package

Sterile medical device delivered to studio in sealed package. Customer’s RA says: capture in package.

A) Capture in package; preserves sterility; outer label + packaging photography is the deliverable
B) Open package anyway — sterility doesn’t matter for photography
C) Refuse to photograph
D) Open in clean zone only

Source: SPMED03 §2.

Explanation: Customer’s RA / SPD decides what to open. Specialist executes; doesn’t override sterility decisions.

Q4 multiple-choice · ppe-cleanroom

Specialist works inside customer’s ISO 7 clean room. PPE?

A) Customer’s clean room SOPs dictate (typically hair cover + face mask + gown + gloves + boot covers + no jewelry/cosmetics)
B) Standard studio dress
C) Surgeon’s scrubs only
D) PPE not needed

Source: SPMED03 §3.

Q5 multiple-choice · equipment-cleaning

PhotoRobot equipment cleaning between medical photography sessions typically uses:

A) Autoclave sterilisation
B) Isopropyl alcohol 70 % wipe (per customer’s protocols); equipment cleaning is disinfection, not sterilisation
C) Bleach solution
D) Distilled water only

Source: SPMED03 §4.

Explanation: Equipment is cleaned (disinfected), not sterilised. Specialty inside-cleanroom work may need sterile equipment (rare engagement).

Q6 scenario · damage-receipt

Sterile product arrives at studio with visible packaging damage (potential sterility compromise).

A) Capture anyway; problem belongs to upstream
B) Pause; escalate to customer’s QA + RA; SPD may need to inspect; don’t proceed without authorisation
C) Discard the product
D) Re-seal the package

Source: SPMED03 §2 + Workbook Ex 5.

Explanation: Sterility chain decisions = customer’s QA/RA/SPD. Specialist escalates; doesn’t make the call.

Q7 true-false · glove-change

Specialist should change gloves between different products being photographed in the same session.

True ← CORRECT
False

Source: SPMED03 §4.

Explanation: Different products = different chain-of-custody. Glove change between handling preserves the chain.

Q8 multiple-choice · scope-boundary

Who owns sterility validation in customer’s medical engagement?

A) PhotoRobot Specialist
B) Customer’s QA + SPD (sterile processing department); Specialist owns studio + capture-side discipline
C) FDA inspector
D) Joint with no clear ownership

Source: SPMED03 §6.

Explanation: Customer owns sterility validation. Specialist operates within customer’s framework; doesn’t replace SPD.

Q9 scenario · documentation

Studio just cleaned between products. What goes in the cleaning log?

A) “Cleaned”
B) Date + time + operator + cleaning agent used + surface(s) cleaned + verification (visual check / wipe test) + any anomalies noted
C) “OK”
D) Nothing — verbal record sufficient

Source: SPMED03 §5.

Explanation: Audit-grade records. Vague entries = audit risk.

Q10 multiple-choice · scope-tradeoff

Throughput in medical photography vs standard product photography?

A) Same
B) Faster (more efficient process)
C) Slower — typically 30-50 % lower throughput than standard product photography (cleaning + documentation + validation overhead)
D) 10x slower
Total: 10 questions
Multiple choice: 9
True/False: 1
Drawn per attempt: 4

Source: SPMED03 training notes Q&A.

Explanation: Medical = elevated discipline = lower throughput. Plan accordingly when quoting medical engagements.

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